As Life Science professionals with niche skills sets our clients are provided with an innovative, network based, qualitative service that produces results on hard to fill roles. The professionals we engage with are provided with invaluable technical and cultural insight into client companies ensuring they are sufficiently prepared to successfully engage in hiring processes. Our technical expertise across numerous verticals within the sector further enables us to interact on a meaningful basis with key decision makers so that we fully understand strategic technical and cultural fits.


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RECRUITMENT

CLIENT

Aphex’s industry experienced resourcing professionals have hands on experience working within Validation, Laboratories, Supply Chain, Procurement, Automation functions within the Life Sciences sector. Our professional qualification and verification approach ensures clients receive the most qualified professional. Contact us to manage your resourcing requirements.

PROFESSIONALS

Our value add is simple, you will be engaging with professionals that have proven and current experience of the Life Sciences industry with strong insights to client companies. This ensures that ambitious professionals are briefed and prepared accordingly throughout the rigours of the interview process, thus enhancing the probability of securing their next position.

PROFESSIONALS

Our value add is simple, you will be engaging with professionals that have proven and current experience of the Life Sciences industry with strong insights to client companies. This ensures that ambitious professionals are briefed and prepared accordingly throughout the rigours of the interview process, thus enhancing the probability of securing their next position.

AVAILABLE VACANCIES

9575436 - Project Scheduler / Planner - Dublin

Purpose:

Position drives the planning of Working Cell Bank, Drug Substance, Drug Product and Finished Product production schedules for the internal and external manufacturing sites to insure product needs of Commercial and Clinical Operations are met for all Metabolic products. Provides both short and long term planning oversight and optimization of product inventories, manages data, and provides reports to internal and external leaderships teams. The successful applicant will have very strong leadership competencies and capabilities and therefore possess the capability to progress through the company organization into roles of increasing responsibility in the future.

 

Responsibilities:

  • Provides short and long term planning oversight and optimization of inventories of working cell bank, drug substance, drug product and finished product in the relevant suppliers, countries and distribution centers, including New Product Introduction.
  • To perform key scenario planning analysis based on supply chain challenges for GSC Leadership team review.
  • Drives the commercial demand review process with relevant commercial stakeholders.
  • Supports reconciliations for all stock locations and provides end of month data/reporting to Corporate Finance and External Audit Partners.
  • Work closely with regional commercial partners to understand sales forecasts, both performance against plan and anticipated changes, insuring inventory levels and production schedules can support market requirements.
  • Monitors compliance to the plan across the entire supply network.
  • Ensures data accuracy in all aspects of planning, as well as in the global planning ERP system.
  • Support the design and implementation of Supply planning metrics.
  • Ensuring compliance to Standard Operating Procedures and Good Distribution Practices.

 

Minimum Qualifications and Experience:

  • Third Level Degree qualification in a relevant discipline is desired.
  • 4 years+ in Supply Planning or associated experience.
  • Advanced level in MS Excel and intermediate level in other MS applications essential.
  • OMP Plus Planning Software Experience essential.
  • Advanced analytical skills and high attention to detail essential.
  • Strong knowledge of Supply Chain Planning concepts and strategies.
  • Prior experience with Advanced Supply Chain Planning Systems essential.
  • Knowledge of planning processes and distribution planning principles.
  • Ability to cope with fast-paced and dynamic business environment.
  • Prior SAP functional skills are preferred but not essential.
  • Familiarity with concepts of cGMP.
  • Ability to communicate and lead cross functional projects.

 

9709 - Validation Analyst - Carlow

Purpose:

Responsible for providing process, technical, and validation support operations including ongoing support of manufacturing processes and support for new product introduction. Accountable for analytical/engineering studies associated with the development of new components, products, processes systems and facilities. Co-ordination, design and execution of equipment qualification. and validation as required.

 

Responsibilities:

  • Serve as technical and/or validation support as required for manufacturing and new product introduction.
  • Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support.
  • Provide technical input into quality notification by authoring/reviewing/approving investigations.
  • Execution of equipment commissioning and qualification programs.
  • Execution of equipment/qualification validation programs; including re-qualification and revalidation.
  • Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process.
  • Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
  • Support continuous improvement through Lean Six Sigma methodologies.
  • Leading and active participation in projects, system failure investigations and investigation reports.
  • Execution/development of change controls.
  • Contribution to Kaizen events as appropriate.
  • Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.;
  • Implement subsequent corrective action through the change management system.
  • Serve as technical engineering representative for internal technical group discussions and represent the company at global technical forums.
  • Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
  • Drive compliance of company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
  • Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
  • Work collaboratively to drive a safe and compliant culture in Carlow.
  • May be required to perform other duties as assigned.

 

Minimum Qualifications and Experience:

  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Report, standards, policy writing skills required.
  • Equipment and process validation.
  • Sterile filling processes and equipment.
  • Lean Six Sigma Methodology experience desired.
  • Understand the specific responsibilities of all Carlow departments as they relate to ones own department, understanding the business processes ones department supports.
  • Data Analysis.
  • Demonstrable analytical and systematic problem solving skills.
  • Training skills.
  • Negotiation skills.
  • Business acumen.
  • Strategy development.
  • Project management skills.
  • Risk management skills.
  • Progressive people management skills.

 

9206 - Scientific Technical Specialist - Cork

Purpose:

The Analytical Sciences (AS) group require a Technical Specialist with strong analytical experience to provide multidisciplinary expertise and technical support to the Analytical Sciences team. The successful candidate will be responsible for assisting in the effective and efficient running of analytical projects and will be active members within the wider Technology team to provide Technical support, guidance and expertise to ensure the success of the team. A high level of innovation, enthusiasm and drive will be required to deliver technical excellence for a number of analytical transfers, method development, method qualifications, and small scale process optimisation studies. The Scientific Technical Specialist provides in-line technical support to ensure the continued manufacture and supply of quality pharmaceutical products in meeting the company priorities of: Compliance, Supply, Strategy and Profit Plan. This role is responsible for all aspects of method and equipment validation, assisting in the effective and efficient running of the method, equipment validation and small scale optimisation operations programs. In addition, providing on-going technical support to the site in the area of contamination control. Works with moderate work direction and is skilled and knowledgeable to the position.

 

Responsibilities:

  • Knowledgeable in protein chemistry and analytical techniques such as ELISA/Bioassay methods, Method validations, method transfers and Equipment qualifications in a GMP environment.
  • Perform laboratory experiments required to deliver on project timelines.
  • Participate in continuous improvement initiatives, including method optimisation and troubleshooting.
  • Preparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures.
  • Lead and Participate in cross-functional projects, problem solving teams for troubleshooting, and investigations across site.
  • Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc.
  • Adhere to highest quality standards.

 

Minimum Qualifications and Experience:

  • MSc/BSc. qualification (Science.)
  • At least 3 years’ industry experience working with ELISA/Bioassay in a QC/Analytical role group.
  • High level written and verbal communications with advanced PC skills.
  • Self-motivated and ability to work as part of a team with good project management skills.
  • Demonstrated ability to fully realize improvement initiatives.
  • Demonstrated successes in a team environment, such as project teams, problem solving teams etc.
  • Stakeholder management of multiple decision makers, corporate colleagues, cross functional teams.
  • Desired Qualifications/Experience: Minitab, Softmax Pro, JMP, Trackwise
  • Project management qualification such as, Project Management Professional (PMP) Evidence of Continuous Professional Development.

 

9703 - Project Engineer - Tipperary

Purpose:

Reporting to the Automation IT Project Manager, specifically responsible for the PI Data Historian system and related Reporting. The Data historian Senior Engineer will be responsible for the development of key AIT quality documents, such as Quality Assurance (QAPs) and test plans, and for ensuing adherence to the QAPs. This candidate will be required to work closely with the AIT team responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.

 

Responsibilities:

  • Technical design lead for the Data Historian and Reporting solution including integration to other systems such as Process Automation System and BAS.
  • Actively participates in the creation of project deliverables such as design documents, configuration build, installation and validation activities as required by the Automation IT Project Manager.
  • Ensure technical delivery of Data Historian and Reporting systems as endorsed by leadership team to meet business objectives.
  • Site Data Historian and Reporting platform architecture, system ownership and lifecycle management.
  • Defining and maintaining the site Data Historian and Reporting roadmap.
  • Responsible for regular communication to project leadership & multi-functional team stakeholders.
  • Assures all design & project work is completed in compliance with all Regulatory requirements including, Quality (cGLP/GMP’s), EHS, Global Engineering, design & construction directives, requirements & procedures, as well as all Local/Federal Regulatory requirements.
  • Supports the project manager on schedule and budget development and control.
  • Development of the Data Historian and Reporting team resources for the project and other supporting vendors.
  • Supporting development of the Data Historian and Reporting project execution plan, scope of work for the contract firms or specialists, and provide technical guidance during the execution of their work
  • Contributes to a high performance culture by recognising and resolving issues as they arise.
  • Creates Electronic Dashboards to support Business Information Management.

 

Minimum Qualifications and Experience:

  • Bachelor’s Degree in Engineering, Information Systems, Computer Science or the Life Sciences.
  • At least 6 years’ experience providing process control and information systems solutions.
  • Experience directing system design, configuration and application of business processes in a biopharmaceutical manufacturing environment.
  • Experience during project delivery and operations support of Data Historian and Reporting systems. Experience with the following systems is preferred; OSI-PI, PI-AF, RT Reports, Kepware, Factorytalk. Experience with process control systems would also be advantageous.
  • Experience with designing information interfaces, data conversion, and network and infrastructure fundamentals.
  • Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays and problems by utilising technical, project management, and business expertise.
  • Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans.
  • Working knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards. Thorough knowledge of Pharmaceutical Industry Regulations (cGMP/cGLP, OSHA, EPA/EQB) required.
  • Previous experience of Oral Solid Dose manufacturing will be advantageous.
  • Previous experience of high containment manufacturing will be advantageous.

 

9701 - IT Infrastructure Senior Engineer - Tipperary

Purpose:

Reporting to the OEB4 AIT Project Manager, specifically responsible for IT Infrastructure for the OEB4 Project. This candidate will be required to work closely with the OEB4 AIT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.

 

Responsibilities:

  • As the IT Infrastructure senior Engineer for the project you will Manage subordinate IT resources and vendors as required.
  • Develop and/or review SDLC deliverables, compliant with company standards, including but not limited to:
    • Requirements Specifications
    • Requirements Traceability Matrix
    • Functional Specification
    • Design Specification
  • Works directly with the client to gather requirements, design solutions, build a proof of concept and implement solutions.
  • Work closely with company Consultants, company Centre of Excellence and vendors of IT solutions to ensure deliverables meet project requirements, including the interfacing of new equipment with existing site systems.
  • Work closely with the QA-IT and CSV functions and ensure their requirements are met in all deliverables.
  • Participate in Hardware and Software FATs and SATs to ensure company requirements and standards are met.
  • Develop project schedules and document trackers to manage and control project deliverables.
  • Lead IT meetings and support, relevant program meetings.
  • Liaise with stakeholders on the overall project to ensure clear communication between all parties.
  • Ensure compliance with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.

 

Minimum Qualifications and Experience:

  • Relevant Computer Science degree or equivalent.
  • Minimum of 6 years’ experience in a similar role in the Pharmaceutical industry.
  • Experience of large scale enterprise technologies is essential.
  • Strong experience in one or all of the following: Virtualisation technologies, VMWare, Hyper-V, VCenter, SAN Implementation, Design & Optimisation, Fiber channels, Disaster recovery, business continuity.
  • Fluent in English, written and verbal.

 

9700 - Computer Systems Automation Engineer - Tipperary

Purpose:

Reporting to the OEB4 AIT Project Manager, specifically responsible for Computer System Validation (CSV). The Lead CSV engineer will lead the development of key AIT quality documents, such as Quality Assurance (QAPs) test plans, Quality assurance summary reports, ensuring adherence to company and regulatory standards. This candidate will be required to work closely with the OEB4 AIT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems. This candidate will review and ensure vendors compliance with company quality standards. Candidate will represent the CSV function at AIT and other OEB4 project meetings, as required.

 

Responsibilities:

  • As the CSV senior engineer for the project you will manage subordinate CSV resources and provide clear direction for systems validation approach within the project.
  • Develop and maintain Qualification Plans and Test Plans, aligned with the overall project C&Q plan and with the leveraging strategy.
  • Develop templates for all SDLC deliverables, compliant with company standards, to ensure consistent implementation of the validation strategy, including but not limited to:
    • Requirements Specification
    • Requirements Traceability Matrix
    • Functional Specification
    • Design Specification
    • Code Review
    • Test specification/test script
  • Work closely with the QA-IT function and ensure their requirements are met in all deliverables.
  • Align with the company HPV program: leverage existing documents & expertise where feasible.
  • Approval of all AIT SDLC deliverables, ensuring compliance with standards.
  • Provide FAT oversight and perform leveraging assessments.
  • Provide guidance and support to AIT team members tasked with delivery of SDLC documents.
  • Provide input to the development of realistic project schedules and document trackers.
  • Work closely with suppliers / integrators to ensure compliance with company standards.
  • Participate in, and support, relevant project meetings.
  • Liaise with the various stakeholders on the overall project to ensure clear communication between all parties in relation to AIT validation requirements.

 

Minimum Qualifications and Experience:

  • Relevant Computer Science or Engineering degree or equivalent.
  • Minimum of 5 years’ experience in a similar role, ideally in the Pharmaceutical industry.
  • Expert knowledge of GAMP5.
  • Strong experience in one or all of the following systems: PLC/SCADA systems, DCS, MES, OSI PI.
  • Previous experience of Oral Solid Dose manufacturing will be advantageous.
  • Previous experience of high containment manufacturing will be advantageous.
  • Fluent in English, written and verbal.

 

9698 - Senior Automation Engineer - Tipperary

Purpose:

Reporting to the OEB4 AIT Project Manager, specifically responsible for Automation Systems. This candidate will be required to work closely with the OEB4 AIT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.

 

Responsibilities:

  • As the Automation senior Engineer for the project you will Manage subordinate Automation resources, Automation vendors and provide clear direction for the Automation team.
  • Develop and/or review SDLC deliverables, compliant with company standards, including but not limited to:
    • Requirements Specifications
    • Requirements Traceability Matrix
    • Functional Specification
    • Design Specification
    • Code Review
    • Test specification/test script
  • Work closely with vendors of Automation equipment to ensure deliverables meet project requirements, including the interfacing of new Automation equipment with existing site systems, incl. MES and PI Historian.
  • Work closely with the QA-IT and CSV functions and ensure their requirements are met in all deliverables.
  • Participate in Hardware and Software FATs and SATs to ensure company requirements and standards are met.
  • Develop project schedules and document trackers to manage and control project deliverables.
  • Lead Automation meetings and support, relevant program meetings.
  • Liaise with stakeholders on the overall project to ensure clear communication between all parties.
  • Ensure Automation compliance with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.

 

Minimum Qualifications and Experience:

  • Relevant Computer Science or Engineering degree or equivalent
  • Minimum of 6 years’ experience in a similar role in the Pharmaceutical industry.
  • Strong experience in one or all of the following systems: Allen Bradley PLC, SCADA and HMIs, Siemens Desigo, OSISoft PI, RT Reports, PasX MES.
  • Previous experience of Oral Solid Dose manufacturing will be advantageous.
  • Previous experience of high containment manufacturing will be advantageous.
  • Fluent in English, written and verbal.

 

9697 - Utilities Automation Engineer - Tipperary

Purpose:

Reporting to the OEB4 AIT Project Manager, specifically responsible for Building Automation Systems and Utilities Automation systems for the project. This candidate will be required to work closely with the OEB4 AIT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.

 

Responsibilities:

  • As the Building Automation senior Engineer for the project you will Manage subordinate Automation resources and vendors as necessary.
  • Develop and/or review SDLC deliverables, compliant with company standards, including but not limited to:
    • Requirements Specifications
    • Requirements Traceability Matrix
    • Functional Specification
    • Design Specification
    • Code Review
    • Test specification/test script
  • Work closely with vendors of Automation equipment to ensure deliverables meet project requirements, including the interfacing of new Automation equipment with existing site systems.
  • Work closely with the QA-IT and CSV functions and ensure their requirements are met in all deliverables.
  • Participate in Hardware and Software FATs and SATs to ensure company requirements and standards are met.
  • Develop project schedules and document trackers to manage and control project deliverables.
  • Lead Automation meetings and support, relevant program meetings.
  • Liaise with stakeholders on the overall project to ensure clear communication between all parties.
  • Ensure Automation compliance with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.

 

Minimum Qualifications and Experience:

  • Relevant Computer Science or Engineering degree or equivalent
  • Minimum of 6 years’ experience in a similar role in the Pharmaceutical industry.
  • Strong experience in one or all of the following systems: Siemens Desigo, Schneider-ElectricPME, Allen Bradley PLC, SCADA (iFix, InTouch etc) and HMIs.
  • Previous experience of high containment manufacturing will be advantageous.
  • Fluent in English, written and verbal.

 

9682 - Automation Project Manager - Tipperary

Purpose:

Reporting to the Associate Director for Automation, specifically responsible for Management of discrete capital projects encompassing Automation Systems on site. This candidate will be required to manage all aspects of project delivery including budget, scope, vendor management and management of project team on site. The candidate will work closely with other disciplines on site and with above site teams to ensure successful delivery of the overall program.

 

Responsibilities:

  • As the Automation Project Manager, you will be responsible for successful delivery of the project.
  • You will work with the overall project team to develop and manage AT scope from basis of design to project closeout.
  • Partner with local business leadership and project teams to deliver scope for Automation aspects of capital projects bringing knowledge of Automation technologies and the Manufacturing Systems Architecture.
  • Financial accountability for Automation Spend.
  • Understand and educate local project teams on automation standards as they relate to technology selection, system configuration, SDLC, validation, hardware, software environments and business processes.
  • Develop and execute project staffing plans if required.
  • Close liaison with Process Engineering Lead and Engineering Contractors.
  • Drive efficiencies in execution of projects to reduce costs and cycle times based on standards.
  • Engage with stakeholders at all levels of projects, including active participation in Project Steering teams.
  • Ensure that SDLC is appropriately applied.
  • Assist with recruitment of AIT project team, day to day management of team members.
  • Manage and control change within the project to critical project constraints.
  • Work closely with vendors of Automation equipment to ensure deliverables meet project requirements, including the interfacing of new Automation equipment with existing site systems, incl. MES and PI Historian.
  • Work closely with the QA-IT and CSV functions and ensure their requirements are met in all deliverables.
  • Develop project schedules and document trackers to manage and control project deliverables.
  • Liaise with stakeholders on the overall project to ensure clear communication between all parties.
  • Ensure Automation compliance with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.

 

Minimum Qualifications and Experience:

  • Degree in Engineering, computer science or a related discipline. An advanced degree would be advantageous.
  • 10+ year’s experience in pharmaceutical manufacturing industry, including minimum 5 years’ experience in a similar role.
  • Project Management certification would be desirable (e.g. PmP or PRINCE2.)
  • Experience managing multi-functional teams to meet project goals.
  • Experience delivering projects using one or more of the following systems: ABB DCS (MOD300, Advant, 800XA), Emerson DeltaV or other DCS. Experience with the following systems would be advantageous; OSISoft PI, Warem PasX, Allen Bradley PLC/SCADA.
  • Previous experience of API manufacturing will be advantageous.

 

9672 - Process Engineer - Carlow

Purpose:

Responsible for generating and expediting review and approval processes for IPT GMP documentation including but not limited to Quality Notifications, CAPA close out records, IPT Standard Operating Procedures and Standard Work Instructions and change controls. Ensure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety and reliable supply to our customers.

 

Responsibilities:

  • Support manufacturing activities through documentation generation, equipment and process investigations associated with non-GMP activities and completion of quality notifications. Provide input to the MES development process team on technical aspects of MES functionality and serve as MES SME within IPT.
  • Be a document system expert; this will include document review, approval and document system work flow expedition. Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOP’s, SWI’s, training documents, and change controls.
  • Support operation activities through documentation generation, filing, tracking, auditing and efficient maintenance of all associated databases including the maintenance, auditing and archiving of the process documentation system.
  • Support Batch release through timely Quality Notification completion, Interim/summary report generation; meeting batch release requirements.
  • Raise CAPA’s and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system.
  • Complete Customer complaint investigations and Change Controls and ensure they are closed out to support production activities in a timely manner in conjunction with the SCM team.
  • Required to comply with company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
  • Work collaboratively to drive a safe and compliant culture in Carlow.
  • May be required to perform other duties as assigned.
  • Assist in the management and/or assignment of IPT training if required.

 

Minimum Qualifications and Experience:

  • Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
  • Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably GMP setting.

Technical:

  • SAP knowledge and experience required.
  • Proficiency in Microsoft Office and job related computer applications required.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Report, standards, policy writing skills required.
  • Equipment and process validation.
  • Sterile filling processes and equipment.
  • Lean Six Sigma Methodology experience desired.

Business:

  • Excellent communication, presentation and interpersonal skills, to interface effectively with levels of colleagues and with external customers in a team orientated manner.
  • Understand the specific responsibilities of all Carlow departments as they relate to ones own department, understanding the business processes ones department supports.
  • Strong team skills, including ability to coach/develop work teams.
  • Excellent training, facilitation and assessment skills.
  • Risk management skills.
  • Strategy planning and development.
  • Demonstrable analytical and systematic problem solving skills.
  • Strong influencing skills.
  • Flexible approach.
  • Effective time management and multi-tasking skills.
  • Trouble shooting skills.

 

9674 - Process Engineer - Carlow

Purpose:

Responsible for generating and expediting review and approval processes for IPT GMP documentation including but not limited to Quality Notifications, CAPA close out records, IPT Standard Operating Procedures and Standard Work Instructions and change controls. Ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to customers.

 

Responsibilities:

  • Support manufacturing activities through documentation generation, equipment and process investigations associated with non-GMP activities and completion of quality notifications. Provide input to the MES development process team on technical aspects of MES functionality and serve as MES SME within IPT.
  • Be a document system expert; this will include document review, approval and document system work flow expedition. Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOP’s, SWI’s, training documents, and change controls.
  • Support operation activities through documentation generation, filing, tracking, auditing and efficient maintenance of all associated databases including the maintenance, auditing and archiving of the process documentation system.
  • Support Batch release through timely Quality Notification completion, Interim/summary report generation; meeting batch release requirements.
  • Raise CAPA’s and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system.
  • Complete Customer complaint investigations and Change Controls and ensure they are closed out to support production activities in a timely manner in conjunction with the SCM team.
  • Required to comply with company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
  • Work collaboratively to drive a safe and compliant culture in Carlow.
  • May be required to perform other duties as assigned.
  • Assist in the management and/or assignment of IPT training if required.

 

Minimum Qualifications and Experience:

  • Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
  • Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably GMP setting.

Technical:

  • SAP knowledge and experience required.
  • Proficiency in Microsoft Office and job related computer applications required.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Report, standards, policy writing skills required.
  • Equipment and process validation.
  • Sterile filling processes and equipment.
  • Lean Six Sigma Methodology experience desired.

Business:

  • Excellent communication, presentation and interpersonal skills, to interface effectively with levels of colleagues and with external customers in a team orientated manner.
  • Understand the specific responsibilities of all Carlow departments as they relate to ones own department, understanding the business processes ones department supports.
  • Strong team skills, including ability to coach/develop work teams.
  • Excellent training, facilitation and assessment skills.
  • Risk management skills.
  • Strategy planning and development.
  • Demonstrable analytical and systematic problem solving skills.
  • Strong influencing skills.
  • Flexible approach.

 

9571724 - Technical Services Specialist - Dublin

Purpose:

The Senior Specialist Technical Services has primary responsibility for providing technical support of commercial and clinical drug product manufacturing operations performed at contract manufacturing organisations (CMOs.) The successful candidate will be responsible for providing scientific and engineering support through all phases of the product lifecycle, including technology transfer, process scale-up, process validation and routine commercial or clinical manufacturing. The position requires effective cross-functional collaboration with CMOs and internal partners including Manufacturing, Process Development, Engineering, and Quality to provide support for manufacturing.

 

Responsibilities:

  • Provide significant fill-finish technical expertise to support all aspects of the manufacturing of commercial and late stage clinical products at CMOs.
  • Lead troubleshooting efforts and high-level deviation investigations in conjunction with contractors and internal partners (Process Development, Manufacturing, and Quality.)
  • Support all aspects of the manufacturing process from raw material selection and specification through formulation and filling to visual inspection, testing and release.
  • Technical review of change controls for impact to product quality, safety and efficacy.
  • Provide on-floor technical support and troubleshooting at the CMO facility.
  • Identify and then lead process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing.
  • Technical protocol and summary report generation as related to technical studies executed in direct support of GMP manufacturing activities.
  • Collection, organisation, trending, and analysis of GMP manufacturing data.
  • Identify manufacturing best practices across the network and lead or participate in teams to implement best practices.
  • Support establishment of validation plans and evaluation of drug product production site options.
  • Provide SME input for IND, BLA and other technical documents for regulatory agency submission in support of manufacturing process operated at CMOs.
  • Up to 25% international travel required.

 

Minimum Qualifications and Experience:

  • Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.
  • Minimum of five years’ experience in in fill-finish process development and/or manufacturing support with extensive practical knowledge of liquid fill operations.
  • Experienced in relevant unit operations including mixing, formulation, sterile filtration, sterilisation, aseptic processing, component processing technologies, liquid filling and visual inspection.
  • Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product drug manufacturing operations are cGMP compliant.
  • Experience of technology transfers and implementing new clinical and commercial biopharmaceutical manufacturing processes, specifically sterile liquid fill operations.
  • Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.
  • Familiarity with protein handling and processing considerations and how operating conditions can impact Critical Quality Attributes (CQA.)
  • Experience of working with CMOs would be a distinct advantage, demonstrating strong communication and influencing skills.
  • Technical transfer experience & be able to lead transfers for vial filling operations in CMOs and PFC operations,
  • Provide technical support to commercial and clinical drug product manufacturing organisations.
  • Liaise between with CMO’s and company GPD.
  • Review & complete Gap analysis, FMEA’s, protocols, report and risk assessments.
  • Travel for F2F, witness / on the floor tech support to Engineering runs & process validation runs.
  • Work with minimum supervision, ability to learn quickly and has strong technical decision making skills.
  • Ability to produce and present to Sr. Mgt – such as slide deck presentations on project status / data assessments.
  • Aseptic processing.
  • Experience with DP TT – Vial filling essential, PFC an added bonus.
  • Must have DP Technical Services/ Technical Transfer experience. Having been a lead in TT is preferable.

9568735 - Cleaning Validation Specialist - Dublin

Purpose:

The Cleaning Validation Technical Specialist will support the cleaning validation activities for the cGMP manufacture of biological bulk drug substance (BDS) at the facility in Dublin. The Specialist will provide cleaning validation expertise to support the start-up cleaning verification/validation and routine commercial manufacturing. The Cleaning Validation Technical Specialist will be responsible for validation and verification of the cleaning used to support the technology transfer of new or existing drug substance manufacturing processes to the facility, and will be required to work in close collaboration with Operations, Engineering, Quality Assurance and Quality Control, and other involved departments to ensure successful facility startup and cleaning verification/validation activities. The position is accountable for timely completion of cleaning validation/verification related milestones, with particular emphasis on cleaning validation for a multi-product drug substance manufacturing facility.

 

Responsibilities:

  • Maintain/update input to the Cleaning/Validation Master Plan to support the startup of the multi-product drug substance manufacturing facility.
  • Develop and implement/update cleaning strategies for fixed and mobile parts.
  • Development/update and/or optimize cleaning (CIP) cycles/methods/recipes for buffer and media preparation systems, upstream (bioreactors) and downstream equipment trains, parts washers and supporting process equipment for new product introductions.
  • Generate and execute cleaning validation protocols as required. Provide input to Standard Operating Procedures (SOPs) and Work Instructions (WI) to enable suitable cleaning sampling activities to occur.
  • Work closely with colleagues within the Technical Services team, and with Quality, Manufacturing Operations, and Automation MCS to ensure CIP recipes, batch record instruction and standard work practices meet the needs of process transfer, and routine manufacturing timelines in the context of cleaning verification/validation.
  • Author and review process transfer/cleaning documentation, cleaning risk assessments, technical protocols and reports, cleaning verification/validation documents and supporting documentation as required. Lead/facilitate and partake in cleaning verification/validation deviations and exceptions to support closeout of verification and validation protocols.
  • Prioritize cleaning verification/validation activities in line with the project schedule to ensure product submission timeline is met, and regulatory approval attained.
  • Identify requirements for process, plant, or laboratory studies/trials to support cleaning verification/validation activities and to liaise closely with Operations/QC to oversee the design and execution of studies (as required).
  • Identify and implement improvements where feasible.
  • Lead the execution of cleaning trials and studies, verification and validation protocols on the manufacturing floor at commercial scale relating to typical BDS manufacturing areas.
  • Temporary shift working may be required during periods of engineering batch and validation batch execution, and participation in on-call roster.
  • Provide on the floor support for troubleshooting cleaning related issues and may lead manufacturing investigations into process deviations.
  • Author and review technical documents for SOPs, master data, material specifications and/or regulatory agency submissions which related to cleaning activities.
  • Serve as a subject-matter expert on cleaning validation activities during regulatory agency inspections.

 

Minimum Qualifications and Experience:

  • Minimum requirement B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering or similar qualifications.
  • Minimum 2-3 years’ plus experience in Technical Services / Manufacturing / Technical Development/Quality Support in a biological bulk drug substance manufacturing organization.
  • Technical and operational knowledge of Cleaning validation/verification, quality systems and regulatory requirements across multiple health authorities.
  • Experience of cleaning verification/validation is a must, and/or cleaning approaches to multiproduct is advantageous.
  • Experience of cleaning verification/validation of upstream (bioreactors, tanks) and downstream processing equipment (Chromatography skid, UFDF/TFF skids, Filtration skids, and process hold vessels.)
  • Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
  • Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization.
  • Ability to present and successfully defend technical and scientific approaches in both written and verbal form.
  • Ability to drive for results independently and adapt to rapidly changing priorities.

9613 - Project Engineer - Cork

Purpose:

The role of the Project Engineer is to Project Manage and Task Supervise Projects in the facility on behalf of the Engineering Department so that Projects are carried out in a compliant manner with all Site Procedures, Global Engineering standards and specifications. The role involves executing a large range of Projects from Facilities to Utilities and ensuring contractors perform and deliver to scheduled and budgeted expectations. Projects to be executed using our defined Project Execution Strategy. The incumbent will be responsible for ensuring there is a strong safety culture and performance in the execution of capital projects. The Project Engineer will report to the Engineering Projects Lead and will work closely with Area owners and Permit issuers. They will ensure all RAMS and Permits are correctly populated and approved for Project Works.

 

Responsibilities:

  • Develop project plans and successfully execute them according to established schedule, cost and performance standards.
  • Track and report progress by issuing regular Scorecards and Schedule updates.
  • Ensure accountability of all project personnel on responsible projects
  • Manage design, construction, commissioning and qualification, schedule and cost in collaboration with other project team members, operations personnel, outside contractors and suppliers.
  • Take an active part in the evaluation and selection of external partners such as engineering consultants and contractors. Collaborate with and manage external consultants and contractors in building projects to ensure that project tasks and deliverables are being achieved.
  • Liaise with Area Owners to ensure operational requirements are included in all Project related interruption and outages.
  • Liaise with key stakeholders and ensure buy in up front on project requirements and impact on stakeholders dept/ area during and after execution.
  • Follow site Project Execution guidance standard and Portfolio Management Office tools and templates as required.
  • Generate Handover criteria for customers and ensure that Project Handover files are received and filed per company requirements.
  • Develop Charters with Customers for approval.
  • Create MOC, SOW, URS and RFC documents for Projects.
  • Manage Enablon’s and close in a timely manner.
  • Ensure the maintainability of new and modified installations.
  • Ensure all work is conducted within EHS guidelines and standards and all works conforms to Company’s EHS policy.
  • Act as company POC for OEP run Projects and support other programs on site as required.
  • Manage costs by forecasting and monitoring spend on projects.
  • Create Snag lists and ensure Projects are completed to a high standard of Quality.

 

Minimum Qualifications and Experience:

  • Degree or 3rd Level Qualification (Engineering.)
  • 5+ Yrs. working in a similar role with relevant experience in the project management of capital projects in a high-tech industry, preferably in Pharma/Bio Pharma.
  • Desirable to have qualification in Project Management.
  • Desirable evidence of Continuous Professional Development.
  • Must have a thorough understanding and application of engineering principles, concepts, industry practices and standards.
  • Proven track record in delivering Projects.
  • Must have meticulous planning and strong communication skills
  • Ability to work on own initiative to resolve issues.
  • Demonstrated high level of problem-solving skills.
  • Advanced PC skills such as Excel, Word, PowerPoint, MS Project or Primavera (SAP, MIDAS, TRACKWISE and SharePoint use experience also an advantage)
  • High level of knowledge of Safety, Quality and Environmental requirements.
  • Excellent verbal and written communication skills/presentation skills.
  • Ability to plan, prioritise and effectively manage time, meet deadlines and produce quality deliverables.
  • Proven knowledge, appreciation and experience of working in strongly regulated GMP environment.
  • Understands the typical project life cycle from concept through to qualification and has proven experience in this area.

 

9563619 - Technical Services Specialist - Athlone

Purpose:

The Technical Services Specialist has responsibility for providing technical support to clinical biologics start up at the company manufacturing facility. The Athlone biologics facility will utilize single use systems for upstream cell culture processing, and a combination of single use and traditional stainless steel systems for downstream purification processing. The position is accountable for timely completion of technical transfer related milestones, with particular emphasis on new product introduction, Technology Transfer, supporting start-up studies, building process data packs and performing process monitoring, study protocol generation, execution and report writing. The position requires effective cross-functional working relationships with Manufacturing, Engineering, Facilities, Logistics, Quality Assurance and Quality Control groups which support day-to-day operations; interacting with Process Development and Analytical sciences for introduction of new products; and providing support for Regulatory submissions to ensure successful facility start up and process qualification. The position will be based in the company’s manufacturing facility in Athlone.

 

Responsibilities:

  • Provide significant technical expertise to support all aspects of the mammalian bulk drug substance cell culture and purification manufacturing at the Athlone biologics Facility.
  • Process SME to support commissioning, automation and manufacturing operation teams.
  • Support technology transfers of new products into the Athlone Facility.
  • Lead troubleshooting efforts and deviation investigations in conjunction with internal partners (Process Development, Manufacturing, and Quality etc.)
  • SME for introduction of single use systems and assessment of their use in terms of extractables, leachables.
  • To author and review process supporting documentation, process descriptions, gap assessments, technical protocols and reports, process validation documentation, strategy documents.
  • To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Material updates, material specifications.
  • To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines.
  • Technical review of change controls for impact to product quality, safety and efficacy.
  • Provide on-floor technical support and troubleshooting.
  • Partner with Operations to support protocol completion, execution and sample reconciliation.
  • To generate documentation reports for technical studies.
  • Lead any key process changes using change control management system as required.
  • Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits.
  • Ensure compliance with site EHS policy, cGMP and other business regulations.

 

Minimum Qualifications and Experience:

  • Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.
  • Experience in technical services support in the manufacture of mammalian drug substance cell culture and purification and/or process development and/or manufacturing support.
  • Experienced in relevant unit operations including vial thaw and scale up, seed train and production bioreactors, harvest, chromatography, UF/DF, viral filtration and inactivation, final formulation and media and buffer preparations.
  • Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices.
  • Experience of technology transfers and implementing new clinical and commercial biopharmaceutical manufacturing processes, specifically in the manufacture of mammalian bulk drug substance operations.
  • Prior experience of single use systems (bioreactors, single use mixers) would be an advantage.
  • Ability to present and defend technical aspects of manufacturing operations.
  • Self-motivated, detail orientated enjoys the fast pace environment of startup.

 

9629 - IT Automation Engineer - Dublin

Purpose:

Reporting to the AIT BMS Lead, specifically responsible for Building management Systems. This candidate will be required to work closely with the AIT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.

 

Responsibilities:

  • Develop and/or review SDLC deliverables, compliant with company standards, including but not limited to:
    • Requirements Specifications
    • Requirements Traceability Matrix
    • Functional Specification
    • Design Specification
    • Code Review
    • Test specification/test script
    • Etc
  • Work closely with vendors to ensure deliverables meet project requirements.
  • Work closely with the QAIT function and ensure their requirements are met in all deliverables.
  • Participate in Hardware and Software FATs and SATs.
  • Provide input to the development of project schedules and document trackers.
  • Participate in, and support, relevant project meetings.
  • Liaise with stakeholders on the overall project to ensure clear communication between all parties.
  • Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.

 

Minimum Qualifications and Experience:

  • Relevant Computer Science or Engineering degree or equivalent.
  • Minimum of 3 years’ experience in a similar role, ideally in the Pharmaceutical industry.
  • Fluent in English, written and verbal.
  • Strong experience in one or all of the following systems: Siemens Desigo CC/Insight, Xworks and PX controllers. Utility systems experience would be an advantage on Chilled water, Hot water and steam generation systems.
  • Technical proficiency on controls systems including familiarity with control panels, networking, panel/field wiring and PLC control systems.

 

9416 - CSV Engineer - Dublin

Responsibilities:

  • Generates, revises and executes CSV documentation for analytical instruments, process equipment and facility computer systems and software ensuring compliance with 21 CFR Part 11, ICH Q7 Sections 12 and 13, Eudralex Volume 4 Annex 15, GAMP and other regulatory and industry standard requirements as deemed necessary.
  • Works with Manufacturing (MFG), Engineering (ENG), Facilities (FAC), Quality Assurance (QA) and Information Technology (IT) to schedule CSV activities. Manages or supports the CSV plan supporting overall project timelines and site objectives.
  • Partners with Quality Assurance IT (QAIT) to ensure policies and procedures reflect up to date regulatory expectations for CSV.
  • Responsible for leading or participating in risk assessments associated with CSV activities.
  • Generates, revises and/or reviews plans, policies, procedures, reports, specification documentation and vendor qualification documents related to CSV.
  • Responsible for providing input, as required, for design documentation to ensure system life cycle for automation of new and upgrades to existing production equipment.
  • Responsible to participate in both factory and site acceptance testing for new manufacturing and engineering equipment, as related to CSV.
  • Resolve CAPA’s, nonconformances, protocol incidents, and change controls related to CSV protocols.
  • Serves as a computer system validation subject matter expert for client and regulatory audits.
  • Responsible for attending client meetings as an Engineering representative for purposes of addressing CSV.

 

Minimum Qualifications and Experience:

  • BS in a Computer Science or Engineering field or equivalent experience.
  • 6 years’ experience with Computer systems validation.
  • 4 years’ experience working in a GMP environment.
  • Experience with GAMP is essential.
  • Experience in biotech and pharma is preferred.
  • Experience with DeltaV is essential.
  • Experience with MES, PI is a plus.

 

9620 - Automation and IT Engineer - Dublin

Responsibilities:

  • Work with Automation & IT Business Analyst in designing, implementing and qualifying a new Manufacturing.
  • Execution System deployment for a start-up Biotech site.
  • Define IT and functional requirements for the MES solution.
  • Develop detailed designs, implement and test MES solutions that meet site requirements.
  • Develop/review/approve IT documentation required for system validation.
  • Manage the delivery of IT systems including servers, clients and additional IT equipment as part of the overall system delivery.
  • Participate in execution of IOQ protocols for the MES Servers and additional IT equipment.
  • Partner with internal departments & external vendors to assist in implementing the Manufacturing Execution System.
  • Participate in the development of MES system development life cycle strategy and technical processes for change management.
  • Develop and improve system processes and procedures.
  • Trouble shooting system issues to define root cause, working in collaboration with Operations, Quality and CoE to build temporary/permanent solutions.
  • Define Data Integrity requirements.
  • Assist in testing of data integrity requirements.
  • Work with site AIT department on generation of SOP’s (Business Continuity plans, backup strategy…etc).
  • Define and create change control documentation required for system changes.
  • Administration and maintenance of site MES systems.

 

Minimum Qualifications and Experience:

  • Eng in Engineering, BSc in Computer Science, or other technical degree.
  • 5 or more years of experience in project/automation/IT support and/or Vaccines / Pharmaceutical Manufacturing front line supervision.
  • Excellent understanding of cGMPs, SDLC methodologies and LEAN/MPS/ Sigma principles.
  • Demonstrated ability to analyse and define business problems, develop business cases, and identify appropriate process and technological solutions is essential.
  • Proven facilitation, meeting/workshop management and change management skills are essential, along with excellent written and oral communication skills, as well as strong presentation skills.
  • Experience with Manufacturing Execution systems such as Werum PAS│X, Emerson Syncade or alternatives.
  • Knowledge of Relational Databases including SQL Server and Oracle.
  • Working knowledge of VMware, MES IT infrastructure, Firewalls, Active Directory as well as ISA- 95 and ISA-88.
  • Desired:
  • Strong understanding of qualification of IT systems.
  • Strong experience with the Werum PAS│X Manufacturing Execution System.

 

9621 - Business Consultant - Dublin

Purpose:

The site Knowledge Management (KM) Site Lead will help unlock & retain site knowledge for business continuity and enable the flow of critical knowledge for products and processes (technical and business) within the site as well as between key partners and organization. The KM Site Lead will leverage the KM CoE to help identify site needs and opportunities to improve and promote knowledge flow with a focus on key products and processes that enabler product realization activities, from commercialization, launch, & supply (e.g. capture of tacit knowledge, technology transfers, investigations, etc.)

 

Responsibilities:

  • Leverage company KM strategic imperatives to ensure site knowledge is managed as an asset for business continuity, foster collaboration, ensure connectivity and enable the greatest value from project and site knowledge.
  • Champion knowledge flow within the site and across other sites in the supply chain that manufacture the key products of the site. KM CoE will support and enable with training, coaching, standard work, tools, techniques, templates, guides and other assets. The OpU KM Business Partner will be a key linkage to the KM CoE.
  • The KM Site Lead will be an active member of a KM practitioner community with leads from other sites and functions and have the opportunity to partner in development of new KM capabilities at a regional or global level. The individual will be engaged with the full KM community across the company network, gaining insights about other sites, functions and leadership.
  • Partner with site leadership team members and their respective teams to evaluate and identify areas of opportunity/gaps in knowledge flow (pain points) for prioritized areas , leveraging assessments and knowledge mapping as appropriate.
  • Develop and maintain the site KM plan that links to the site Hoshin, objective and Operating Units KM focus areas.
  • Lead deployment of the site KM plan, as linked to the site objective and priorities.
  • Measure progress against the site KM plan. Gather, monitor and report progress of KM initiatives to site and KM CoE leadership with metrics.
  • Serve as the site KM SME and lead KM practitioner providing the following:
    • After Action Review (AAR) facilitation as a certified AAR practitioner.
    • Knowledge mapping.
    • Training for KM Tools TK, Take 5, Vitual Talent Network and any other standard KM tools.
  • Support the design, implementation, and enhancement of core KM approaches used to support capture and share critical knowledge flowing critical knowledge flow within key site business processes and between the site and global organizations supporting the commissioning, qualification and filing.
  • Ensure site content is managed in a way to allow site personnel to find and utilize knowledge in an efficient manner.
  • Responsible for deployment of new KM capabilities at the site and determines where core KM capabilities should be deployed, utilized and leveraged to business benefit.
  • Provide valuable feedback to the KM CoE on KM business impacts and contributes to next generation solutions through participation on benchmarking activities.

 

Minimum Qualifications and Experience:

  • Bachelor’s degree in a Science or Engineering discipline.
  • Desirable to have a Masters in a related discipline.
  • A minimum of 5 years experience working on a biopharmaceutical manufacturing site.
  • Evidence of Continuous Personal Development.
  • Desirable: Six Sigma Green Belt.
  • Demonstrated ability to design and facilitate workshops, meetings, and/or large or small groups to drive successful outcomes.
  • Clear understanding of business situation and processes, and can map processes as required, and good working knowledge of organizational and business strategy.
  • Ability to contract with and influence leaders in the organization, good at networking, collaboration and sharing of ideas and success.
  • Ability to elicit requirements and anticipate customer needs, at both operational and strategic levels, and ability to deliver solutions that meet or exceed customer expectations.
  • Ability to think strategically for long term vision and in terms of culture, behavior, business processes and tools yet can meet tactical needs and tailor solutions to be fit-for-purpose.
  • Creative, innovative, self-motivated, applies problem-solving skills (thinks outside of the box) and systems thinking skills.
  • Has a understanding of KM principles and first-hand experience in KM techniques desirable, such as professional networking / social media; taxonomies; expertise location; best practices transfer; lessons learned; and other common processes.
  • Understanding of Lean diagnostics techniques including SIPOC and process mapping to elicit customer requirements and design solutions to meet these requirements.
  • Understanding of pharmaceutical product lifecycle phases including typical types of product and process knowledge. Experience generating or managing product and process knowledge in the commercialization / product manufacturing lifecycle phase of pharmaceutical manufacturing is desired.

 

9403 - Automation Engineer - Carlow

Purpose:

Reporting to the DeltaV Workstream Lead. The Automation Engineer will be responsible for the development of key documentation, test protocols, and for ensuing adherence GAMP practices. This candidate will be required to work closely with the site’s AIT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.

 

Responsibilities:

  • Be part of the DeltaV team contributing to the completion of a large-scale project
  • Support the project on a day to day basis for the DeltaV System including: Design and test documentation generation, reviewing and approving
  • Supporting of PLC system interfacing with the DCS system
  • Design, Review, Approve SDLC deliverables, compliant with company standards, to ensure consistent implementation of the validation strategy, including but not limited to:
  • Requirements Specification
  • Requirements Traceability Matrix
  • Functional Specification
  • Design Specification
  • Code Review
  • Test specification/test script
  • Work closely with QAIT and ensure their requirements are met in all deliverables
  • Participate in Hardware and Software FATs
  • Provide input to the development of realistic project schedules and document trackers
  • Work closely with suppliers / integrators to ensure compliance with company standards
  • Participate in, and support, relevant project meetings
  • Liaise with the various stakeholders on the overall project to ensure clear communication between all parties in relation to AIT validation requirements.
  • Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions

 

Minimum Qualifications and Experience:

  • Relevant Computer Science or Engineering degree or equivalent
  • Minimum of 3 years’ experience in a similar role, ideally in the Pharmaceutical industry
  • Working knowledge of GAMP5
  • Excellent knowledge of DeltaV
  • Knowledge of the following systems beneficial: PLC/SCADA and OSI PI
  • Previous experience working with the company will be advantageous
  • Fluent in English, written and verbal

 

2019-289 - Supply Chain Specialist - Waterford City

Purpose:

Production planner within a high performing supply chain planning team. It is an exciting opportunity to work on new products to site, to build strong supply chain processes and be part of a new and growing business. The role works closely with all functions and in particular with Operations, Quality, Demand and Finance teams.

 

Responsibilities:

  • Work closely with demand team to ensure that customer needs are understood
  • Working with operations to plan production lines to meet customer needs
  • Ensure that all Quality and GMPs standard are followed
  • Monitor aging inventory for area of responsibility
  • Achieve key KPI’s – Service level, No out of stocks, Schedule adherence

 

Minimum Qualifications and Experience:

  • Degree level or above, APICs desirable
  • 3 years + experience in production planning ideally in a pharma or GMP environment
  • Strong knowledge of MRP, MPS, IBP, Class A metrics
  • Knowledge of ERP – SAP
  • Strong Excel and IT skills

 

2019-288 - Principal Engineer - Reliability and Maintenance - Waterford City

Responsibilities:

  • Design and optimize maintenance strategies, procedures and methods of work execution.
  • Lead the planning and scheduling of routine maintenance work.
  • Lead A3 project team to resolve repetitive equipment faults or process instabilities.
  • Working with Maintenance/Engineering to optimise planned maintenance routines.
  • Carry out quality inspections on jobs, work execution, identify improvements in tasks.
  • Liaise with client departments, customers and other engineering and production colleagues.
  • Arrange specialist procurement of fixtures, fittings or components.
  • Support the control maintenance costs.
  • Work with specialist equipment, such as programmable logic controllers (EAM, HMI), which control machinery on factory assembly lines.
  • Coach maintenance and engineering excellence strategies to help with installation and commissioning guidelines.
  • Deputize for Maintenance or Engineering Manager on occasion.
  • Support planning and scheduling to minimize impact to HVM operations.
  • Act as key site contact for maintenance excellence initiatives.

 

Minimum Qualifications and Experience:

  • 10+ year’s experience of maintenance related roles in high-volume industries with a significant technology content. Extensive hands-on experience of systems development and deployment, staff engagement and change management. Knowledge of medical device and/or pharmaceutical production preferred (cGMP / FDA regulated environment).
  • Bachelor’s in engineering or other technical discipline preferred. Experience in managing or leading engineering improvement projects, technical or systems related.
  • Knowledge of auto report generation, PLC I/O machine connectivity and equipment or engineering system reliability metrics development advantageous.
  • Experience in EAM/CMMS systems and system development.
  • MRO stores systems experience.
  • Proven ability to support Electronic Asset Management System deployment and technology development.
  • Self-Directed, excellent communication skills on technical subjects. Ability to form relationships with stakeholders from many sites and work within cross functional teams.
  • Experience of building effective MRO stores operating systems, Space management, new technology development for inventory control and cycle counting.
  • Excellent teamworking skills to work cooperatively and liaise with people at all levels.

 

2019-287 - Shift Engineer - Maintenance and Reliability - Waterford City

Purpose:

Improve equipment performance and reliability through technical knowledge and people leadership. This role will include the planning & execution of preventive and reactive maintenance programmes and the leadership of a group of technicians on shift. Technical knowledge & and employee supervision, and development are key aspects of the job.

 

Responsibilities:

  • Implement preventative maintenance programmes.
  • Monitor and drive improvements in the effectiveness of all maintenance activities.
  • Develop training plans for technicians.
  • Own, monitor and report and implement improvements in equipment OEE.
  • Provide details of shortfalls and associated improvement plans.
  • Set goals for the shift technician group.
  • Propose and action projects designed to improve all relevant maintenance KPIs etc.
  • Participate in the recruitment of staff as required.
  • Work with Procurement and Logistics groups on the control of equipment spares.
  • Complete Quality and Safety CAPA activities.
  • Ensure all work is executed in line with health and safety and quality system requirements.

 

Minimum Qualifications and Experience:

  • Education: Bachelor’s Degree in Engineering or other relevant, technical equivalent.
  • Experience: 5+ year’s experience of engineering/ maintenance roles in high-volume industries with a significant technology content
  • 3+ year’s supervisory experience advantageous.
  • Extensive hands-on experience of preventive/ reactive maintenance, technician supervision/ interaction and high-speed automation.
  • Knowledge of medical device and/or pharmaceutical production preferred (cGMP / FDA regulated environment).
  • Knowledge of automatic measurement and reporting of OEE and related production data would be advantageous.

 

2019-286 - Senior Project Chemist - Waterford City

Purpose:

The Senior chemical project engineer is instrumental in providing technical support to the different departments on site and will ensure that the tasks are completed ensuring compliance to all quality standards and adherence to GMP requirements. The person is responsible to track any Quality related issues with the secondary source raw material supply and non-routine projects and attend meetings to ensure that all activates are identified to the relevant departments.

 

Responsibilities:

  • To ensure technical support is provided for the second source supply of raw materials validation project for the contact lens.
  • To ensure Supplier Quality Engineer Support is provided for the secondary source raw material validation project.
  • To complete analysis on the second source project raw materials, in process materials and finish product.
  • To provide support the non-routine activities that occur within the contact lens and to complete investigational analysis to help support the release of material or the required validation of a new material.
  • To provide Quality support for the contact lens to ensure it meets FDA and NSAI requirements.
  • To assist in any validation activities that may occur within the monomer/ solution area as the technical representative within the project.
  • To provide guide in customer audits in the laboratory, assist in the internal auditing program and external audits as technical support or Supplier quality support.
  • To Complete the qualification activities required to new or existing vendor as part of the secondary source project.
  • To complete any analysis or activities from an analyst requirement for any engineering documents being undertaken.

 

Minimum Qualifications and Experience:

  • A minimum of 5 years work experience in a QC laboratory or a QA environment.
  • Good communication skills.
  • Full understanding of the requirements of the regulatory Standards.

 

9394 - Automation (Computer Systems) Engineer - Carlow

Purpose:

Reporting to the site AIT CSV Lead, specifically responsible for Computer System Validation (CSV). The CSV engineer will be responsible for the development of key AIT quality documents, such as Quality Assurance (QAPs) and test plans, and for ensuing adherence to the QAPs. This candidate will be required to work closely with the site AIT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.

 

Responsibilities:

  • Develop and maintain Qualification Plans and Test Plans, aligned with the overall project C&Q plan and with the leveraging strategy.
  • Develop templates for all SDLC deliverables, compliant with company standards, to ensure consistent implementation of the validation strategy, including but not limited to:
    • Requirements Specification
    • Requirements Traceability Matrix
    • Functional Specification
    • Design Specification
    • Code Review
    • Test specification/test script
  • Work closely with the QAIT function and ensure their requirements are met in all deliverables.
  • Align with the company HPV program: leverage existing documents & expertise where feasible.
  • Approver of all AIT SDLC deliverables, ensuring compliance with standards.
  • Provide FAT oversight and perform leveraging assessments.
  • Provide guidance and support to AIT team members tasked with delivery of SDLC documents.
  • Provide input to the development of realistic project schedules and document trackers.
  • Work closely with suppliers / integrators to ensure compliance with company standards.
  • Participate in, and support, relevant project meetings.
  • Liaise with the various stakeholders on the overall project to ensure clear communication between all parties in relation to AIT validation requirements.

 

Minimum Qualifications and Experience:

  • Relevant Computer Science or Engineering degree or equivalent.
  • Minimum of 3 years’ experience in a similar role, ideally in the Pharmaceutical industry.
  • Expert knowledge of GAMP5.
  • Strong experience in one or all of the following systems: DeltaV, PCS7 (or other PLC/SCADA), OSI PI.
  • Fluent in English, written and verbal.

 

9521 - Senior Project Engineer - Cork

Purpose:

A vacancy exists within our Global Engineering Solutions (GES) group for a Client side Senior Project Engineer (Utilities Clean & Black) supporting GES capital projects in Ireland. A high level of initiative, energy and motivation are key role requirements, as well as excellent organizational skills. The successful candidate will have several years’ experience working in the pharmaceutical or similar Industry. Reporting to the GES Associate Director – Project Management based at the Site. The Engineer will have previous significant experience at a senior level within a >€100MM Project.

 

Responsibilities:

  • Ensure there is a strong safety culture and performance in the design and execution of capital projects.
  • Manages a specific scope of the project to ensure that the performance, cost & schedule criteria are met.
  • Ensure that partners (EPCM & Vendors) are performing to meet the needs of the project and escalating issues if not resolved.
  • Manages inputs to the assigned project scope of the stakeholders ensuring they are informed and consulted on key project activities, progress and decisions.
  • Ensures that key issues/escalations and decisions and backup to same are made visible and are logged appropriately.
  • Liaise with Appointed EPCM to assist with the Management of design, construction, commissioning and qualification, schedule and cost control in collaboration with other project team members, Site personnel, outside contractors and suppliers.
  • Manage capital spend on assigned project scope – engage in estimation to forecasting to financial close-out ensuring a continual focus on cost awareness.
  • Monitor progress of project milestones with all team members and provide status reports.
  • Ensures that good Engineering practices are utilised and aligned with customer’s needs from requirements gathering, through design and execution.
  • Manage project changes and ensure all are captured, documented and assessed for Quality / Safety / Cost or schedule impacts.
  • Coordinate with EPCM the generation and execution of Commissioning & Qualification documentation.
  • Client inputs to the planning of critical fieldworks for vendor engineers and contractors
  • Participate in EPCM led HAZOP and design reviews as lead GES Representative, ensuring stakeholder inputs are coordinated and appropriate.

 

Minimum Qualifications and Experience:

  • Must have as a minimum a 3rd level Degree in Engineering, preferably Chemical or Mechanical.
  • A minimum of 8 years of relevant experience in project management of capital projects in a Biopharma environment.
  • Have SME knowledge of utilities systems (both Clean and Black) and general knowledge and experience of bio-pharma drug product facilities.
  • Preferable to have a qualification in project management – PMP or equivalent.
  • Proven level of experience in being a senior member of a team delivering significant capital projects >€100MM.
  • Ability to coordinate activities to deliver projects to an aggressive schedule.
  • Experience of clean room installations essential.
  • Understands the typical project life cycle from concept through to qualification and has proven experience in this area.
  • Familiar with engineering project management tools, financial management skills including an ability to work within budgets, and engineering technical skills.
  • Proven knowledge, appreciation and experience of working in strongly regulated GMP environment
  • Strong interpersonal skills and an understanding of the customer/client relationship involved in projects.
  • Demonstrated performance and managing multi-functional teams.
  • Demonstrated experience in leading projects from Design to Qualification.
  • Black Utilities Design – Commissionning.
  • Clean Utilities Design – Qualification.
  • Clean Room facility design.
  • Facilities & HVAC Design including BMS.
  • Construction Management.
  • Project Controls.

 

2019-285 - Calibration Engineer - Dublin

Purpose:

The Senior Calibration Engineer will design and implement the calibration programme for our new start-of-the-art- single use multi-product biotech facility. This facility will manufacture enzyme replacement and antibody-based therapies. The role will be the Calibration Subject Matter Expert (SME) in the establishment of the calibration programme, performing maintenance, installation, troubleshooting, calibration and repair of a variety of electronic components, analytical equipment, controls and instruments for site wide laboratory and manufacturing equipment. This is an important role at the plant within the Site Engineering organisation to help create value for our patients.

Responsibilities:

Technical Calibration Servicing: 
  • Provide technical direction, supervision and input for standing up and operation of the calibration programme at the facility to meet functional and site objectives.
  • Responsible for identifying and critically assessing the calibration requirements for plant and
  • equipment, drafting and implementing guidelines, standards and calibration procedures, setting out the calibration plans and schedules, conducting technical investigations, resolving calibration deviations, act as SME presenting at internal and external audits, developing and delivering training, and managing technical specifications and documentation.
  • Perform monitoring, trending of equipment and processes, and determine acceptability and tolerance requirements based on data analysis and specification.
  • Assist with vendor calibration support to equipment; including audits and contracted services to per site requirements.
  • Set up standards and special laboratory equipment to test, evaluate, and calibrate instruments, sensors and equipment.
  • Assist engineers in evaluation plans and procedures, to maintain precision accuracy of measuring, recording and indicating instruments and equipment.
  • Investigate failures and instruments that are out of tolerance and determine acceptability of product and processes. Assist in the preparation of documentation of investigation findings.
  • Assists with development and implementation of technically defensible calibration procedures and new instruments being considered at the Facility.
  • Build and maintain relationships with customers with the concept that metrology is a service provider to the customer.
  • Coordinates the assigned activities and schedules of calibrations throughout the facility, including routine and non-routine work.
  • Makes scientific judgments related to instrumentation problem solving.
  • Enshrines safety, quality and operational excellence in the application calibration across site.
  • Subject Matter Expert and leader for the site calibration programme who works with cross functional teams to ensure that there is an effective and robust calibration system developed and implemented at the site.
  • Responsible for generating of calibration documents, specifications, training programs, and for standing-up the Plant Calibration system, generating and managing Standard Operating Procedures, Protocols, Technical Reports and QMS reports.
  • Ensure that calibration improvement projects are included in the capital plan.
  • Participate in the Site Operations Readiness team interfacing with the projects team to ensure that the project is delivered in accordance with the agreed scope.
  • Work with Maintenance Lead in establishing and meeting targeted site and Tech Ops objectives, ensuring department objectives are aligned, translated to all and visually managed to drive performance results.
  • Conducts performance reviews and development plans.
  • Ensure that calibration budgets are met and adjusted as needed.
Operational and Technical Support:
  • Provide calibration and technical support to ensure stable, efficient and robust operations at the site.
  • Responsible for designing and implementing a best-in-class site calibration programme.
  • Works with the Maintenance Lead to develop an escalation plan for calibration support and designs a plan for out of hours calibration support.
  • Implement a calibration program for assets to support manufacturing and prevent unplanned downtime.
  • Execute change control for calibration activities including writing and executing change control test plans.
  • Responsible for timely updates of achievements and challenges.
  • Works collaboratively on resolving obstacles and building relationships so as to maintain a highly effective and productive work environment.
Project Support:
  • Execute calibration projects and improvement initiatives by following a systematic approach in accordance with financial and business requirements.
  • Accountable for the design, establishment and execution of calibration projects.
  • Ensure that the calibration program is appropriately structured, resourced and staff trained to meet plant goals and objectives and ensure that improvement projects are delivered.
  • Provide appropriate technical input to ensure plant and equipment design, commissioning, qualification and validation is executed per site calibration requirements.
Systems Calibration:
  • Collaborate with Manufacturing, Facilities, Process Development, Automation, Quality Assurance, EHS, Global Engineering, Validations and Maintenance teams in developing requirements and recommendations for calibration enhancements, changes and improvements.
  • Utilise Operational Excellence tools and techniques in completing investigation and implementing technical solutions to resolve complex problems.
  • Establish and maintain best-in-class plant calibration, process and methodologies around the management of instruments and plant equipment in accordance with cGMP and GEP’s.

 

Minimum Qualifications and Experience:

  • Level 8 Bachelor’s degree in Metrology or Instrumentation or equivalent.
  • A relevant postgraduate qualification in validation, engineering, automation or TPM is desirable.
  • At least 6 years’ plus industrial experience, with at least 5 years in pharmaceutical manufacturing, medical devices or equivalent.
  • Must have knowledge of Metrology concepts, including accuracy, precision and uncertainty.
  • Must be able to deal with complex processes
  • Operational Excellence/ Lean Six Sigma qualification or competency in leading, training and/or implementing root cause analysis and effective investigation practices.
  • A background of working in advanced automated manufacturing operations with integrated

 

9520 - Warehouse and Logistics Program Lead - Cork

Purpose:

Lead the portfolio of projects for the Warehouse and Logistics function at the facility. The scope of projects entails working closely with the Operation IPTs projects, SAP Implementation team and new Projects for Warehouse and Logistics, whilst ensuring timely delivery of project milestones and ensuring no disruption to current business. The Project Manager will participate and comply with the Quality Management System (QMS) requirements, including ownership, as relevant to you.

Responsibilities:

  • Facilitating the definition of project scope, goals and deliverables.
  • Creating and executing and revising project work plans as appropriate to meet changing needs and requirements.
  • Managing day-to-day project aspects and tracking deliverables.
  • Identifying resources needed and assigning individual responsibilities in matrix team.
  • Lead a Matrix team, a key role that provides direction and support to project team.
  • Effectively applying methodology and enforcing project standards.
  • Holding regular status meetings with project team and effectively communicating relevant project information to stakeholders.
  • Resolving and/or escalating issues in a timely fashion.
  • Ensuring project documents are complete, current, and stored appropriately.
  • Responsible for supporting a culture of Continuous Improvement by deploying Six Sigma / MPS tools in Hoshin Kanri, Project Portfolio Management, Supply Risk Reduction and site processes.

 

Minimum Qualifications and Experience:

  • Degree or 3rd level qualification (Business, Supply Chain, Science or Engineering.)
  • At least 3 years’ experience in the Pharmaceutical industry or a similar operating environment which includes significant project leadership roles with experience in a matrix structures.
  • Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Manufacturing, Quality, Engineering, etc.)
  • Knowledge of and experience in applying Six Sigma and Lean methodologies.
  • Desirable Project Management qualification such as, Project Management Professional.
  • Preference Lean Six Sigma Green Belt.
  • Evidence of Continuous Professional Development.
  • Professional qualification / business and number of years warehouse/Logistics experiencing in similar environment.

 

9325810 - Training Administrator - Dublin

Purpose:

The Training Administrator performs activities to support the facility in Dublin. Responsible for supporting the day to day training activities on site which include : Creation and revision of Job Roles, assigning of Job Role to employees, creation and revision of learning activities, management of training folders for all staff and contractors , delivery of training if required. Support all internal / external inspections and audits on site.

Responsibilities:

  • Ensure that all employees and relevant contractors have been assigned a Job Specific Curricula (JSC).
  • Management of training files for all employees and contractors.
  • Maintain and update for the site.
  • Maintain training folders for all employees and contractors.
  • Training delivery as required.
  • Other duties as required.

 

Minimum Qualifications and Experience:

  • National second-level qualification e.g. Leaving Certificate is acceptable.
  • Preferred – Third level qualification, e.g. B.Sc. in science or related area.
  • A minimum of 3 years relevant experience within a similar or related field.
  • Strong knowledge of cGMP requirements for pharmaceutical manufacturing and/or packaging required.
  • Direct experience of GMP within a healthcare company is essential.
  • Prior experience in the use of an LMS is desirable
  • The individual in this position is expected to represent company interests, objectives and policies in a responsible and professional manner.
  • Experience of manufacturing processes for pharmaceutical products and processes strongly desirable.

 

9576 - Project Coordinator - Cork

Purpose:

Project Co-Ordinator will provide project scheduling and execution support to the facility in manufacturing quality pharmaceutical products. The team working style is one of collaboration, coaching and facilitating to provide solutions to the team to support a High-Performance Organization. The leadership style is one of collaboration, coaching and facilitating the project team in a high performance organisation. This will require a substantial amount of time within the project process, engaging and communicating with all project members.

Responsibilities:

  • This individual will be a part of a newly formed Project Management Office (PMO), to ensure that the site delivers on key strategic projects and initiatives. These projects fall into but are not limited to the following categories:
    • Engineering
    • Supply Chain
    • Continuous improvement initiatives.
    • Business transformation.
    • Technical Programs
    • Other programs as dictated by company initiatives.
  • Facilitates schedule development sessions with project team and collects data for schedule logic, activity durations and resource requirements.
  • Manages the preparation of schedules for all phases of a project.
  • To work with the team to manage a reliable and responsive planning service for projects.
  • Responsible for ensuring that schedule updates from the various area owners are carried out, and that these inputs are cross checked and consistent with one another to support the overall Program.
  • Ensures that all quality checks are carried out on the Schedule before issue.
  • To analyse project requirements and manage the preparation of a Project Master Schedule which integrates strategies and constraints for all project phases.
  • To monitor progress against schedules, analyse deviations and recommend remedial actions.
  • To co-ordinate, in conjunction with colleagues, a progress measurement system and to operate the performance measurement systems.
  • Establishes working relationships across the Site /Project Teams. Negotiates and monitors levels of service or performance provided, communicates and actions areas of concern to resolve issues.
  • Effectively communicating with and managing key stakeholders both internally and externally.
  • Proactively managing issues, proposing mitigation/response plans to resolve issues and effectively implementing the action plan.
  • Support the development and running of the Project Management Office on site.
  • Performs additional assignments per the PMO Lead’s direction.

 

Minimum Qualifications and Experience:

  • A minimum of five to eight years of relevant experience in project co-ordination and scheduling of a broad spectrum of projects in the Pharma industry.
  • Engineering Degree with 3+ years Scheduling and Planning experience preferably in the Biotechnology and Pharmaceutical sectors.
  • Responsible for supporting a culture of Continuous Improvement by deploying company Lean Six Sigma tools.
  • Demonstrated leadership skills with a continuous improvement focus.
  • In depth experience of MS Project Progress Reporting, Critical Path Analysis and Key resource profiling.
  • Project management qualification such as Project Management Professional etc.
  • Demonstrated ability in holding project team members responsible for results.
  • Demonstrated successes in a team environment, such as project teams, Six Sigma team, PITs etc.
  • Experience with Management Systems such as PM, EHS, Trackwise, SAP, PRINCE, Microsoft PM etc.
  • Influencing, negotiating and conflict management.
  • Understands the typical project life cycle from concept through to qualification in a strongly regulated GMP environments and has significant proven experience in this area.
  • Delivery of effective & accurate project progress reports that can be analysed and understood at all levels within the organization.
  • Responsible for project stakeholder management to ensure effective delivery of project objectives – including escalation management.
  • Creation and control of project plans for departmental, cross departmental, and company-wide projects.

 

2019-278 - Regulatory Affairs Manager - Waterford City

Purpose:

To support the Head of Scientific Affairs with activities associated with the registration of company products (Human and Veterinary) in Worldwide markets including US, EU and Japan, as well as Regulatory Compliance liaison with QA for registered products. To lead and develop the company’s Regulatory team. Supporting the Clinical Affairs teams (Human and Vet) for Regulatory approvals for clinical trials globally as required. To ensure that project plans and milestones are delivered according to agreed timelines and co-ordination of department metrics around same. To ensure department budgets and controls spending in line with Corporate approved annual budgets.

 

Responsibilities:

  • Project Planning/Co-ordination:
    • Together with the Head of Scientific Affairs, actively plan regulatory requirements ensuring major milestone targets for each product are visible to all team members and key stakeholders to achieve on time market entry.
    • Together with the Head of Scientific Affairs, determine tasks and resources required to deliver each project milestone and deliverables.
    • Work with the Clinical Affairs team to support clinical trials by direct responsibility for activities associated with the clinical trials including Regulatory approvals and IMP management.
  • Regulatory Compliance:
    • Oversee licence maintenance support to customers, the company’s Regulatory agents and internal departments within the company.
    • Regulatory Compliance liaison with QA.
  • Licensing Activities:
    • Manage licensing activities for existing Marketing Authorisation applications in Europe, US, Japan, Canada and various markets in South America, Asia and the Middle East.
  • Dossier Preparation:
    • Manage submissions to company target markets, including liaison with R&D, QC, and Production as well as external experts where required.
  • Strategic Planning:
    • Strategic planning of regulatory activities in target markets for company products.
  • Leadership:
    • Coaching/mentoring- support members of team with problem solving and skills development to aid learning and early problem resolution.
  • Recruitment- assist with recruitment of team members in line with resource requirements on to job specification.
  • Manage regulatory affairs budget and cost centre activities.

 

Minimum Qualifications and Experience:

  • Minimum B.Sc. Ideally primary degree in Chemistry, Pharmacy or Pharmacology but any Science related discipline considered.
  • At least 10 years Regulatory affairs experience to include responsibilities in supervisory/people management.
  • Familiarity with cGMP in pharmaceutical manufacturing.
  • Significant experience of Regulatory Approval processes for pharmaceutical products globally.
  • Technical knowledge of analytical/ formulation development of pharmaceutical Products (e.g. solid oral dosage forms, biologics, fill finish, inhalations.)
  • Working knowledge of EDMS (Electronic Document Management System.)
  • Effectively develop and implement plans to accomplish project objectives.
  • Problem Solving/Analysis – secure relevant information and identify key issues and relationships from a base of information; relate and compare data from different sources, identifying cause-effect relationships.
  • Working effectively with team I work group or those outside the formal line of authority (e.g. peers, senior managers) to accomplish organisational goals; taking actions that respect the needs and contributions of others, contributing to and accepting the consensus; subordinating own objectives to the objectives of the organisation.

 

2019-284 - Planning Manager - Waterford City

Purpose:

The Planning manager is responsible for ensuring manufacturing schedules for the Contact Lens and Pharmaceutical plants and are driving the production of the right skus in the right quantity at the right time to maximize customer service while optimizing manufacturing efficiency.

 

Responsibilities:

  • Maintenance of and daily monitoring of DC sku inventory levels against target.
  • Maintenance of relevant Manugisitcs parameters regarding plant capacity and replenishment orders.
  • Ensuring efficient and effective scheduling that balances Customer requirements with maximum production utilization and minimum inventory levels.
  • Focusing on Customer satisfaction through continuous monitoring of established metrics relating to order-fill, backorder and inventory replenishment.
  • Liaising with Operations on backorder and low limit skus.
  • Interpretation and analysis of demand/supply data, and communicate the possible effects on manufacturing performance, inventory levels and Customer Service.
  • Maintenance of Raw Materials Planning parameters in line with MPS and regular liaison with Purchasing staff on relevant issues pertaining to the demand and supply of Raw Materials.
  • Forecasting of lot profiles for Operations and Cartoning to determine setups for coming months/years.
  • Day to day management of Production Planners.
  • Lead projects on Production Planning improvements to manufacturing efficiencies while maintaining Customer Service.
  • Key player in any system developments and enhancements pertaining to improving Planning processes.
  • Execute other managerial and operational disciplines of the Planning Department as and when required. Focus on the continuous enhancement and credibility of the department, within the Organization, through a professional and mature approach at all times.

 

Minimum Qualifications and Experience:

  • Graduate or equivalent professional qualification e.g. A.P.I.C.S Certification.
  • Comprehensive knowledge of Planning/Scheduling/Inventory Management with a detailed understanding of all other Supply Chain functions.
  • Focused on Customer Service and delivering Key Operational Measurements.
  • Ability to use Excel at an advanced level and high level understanding of ERP LX.
  • Manugistics Networks fulfillment version 7.2.

 

8545 - Compliance Specialist - Carlow

Responsibilities:

  • Supports project management team from design to financial closeout.
  • Is knowledgeable of construction industry risks and current events.
  • Reviews, verifies, and analyzes information related to construction project activities.
  • Creates and maintains audit work papers.
  • Understands Contract Scope, terms and conditions, and applies to downstream processes such as Change Management and Invoicing.
  • Makes recommendations for best practices.
  • Provides audit management with recommendations on audit scope.
  • Responds to internal and external customers as needed in a service oriented manner.
  • Consolidates results and recommendations in audit database repository, and follows-up on status.
  • Communicates, in a timely manner, with responsible Project Team members.

 

Minimum Qualifications and Experience:

  • Degree in Accounting, Engineering, Finance, or other relevant discipline.. Experience 5+ of audit and/or construction industry experience.
  • Advanced academic training or specialized knowledge in relevant areas may be considered in lieu of some or all experience.
  • Incumbent must have the ability to work both independently and in a team environment, and be able to effectively interact with all levels of management.
  • Has the ability to research invoice activity and experience with construction project execution (experience with bid and award documents, construction and engineering contract agreements, change management, invoicing ,cost reporting, and schedule).
  • Excellent analytical and communication (verbal, written) skills. Proficient in Microsoft Word and Excel.
  • SAP work experience strongly preferred.

 

9126 - Senior Process Engineer - Cork

Purpose:

Provide process engineering services in support of the design, construction, commissioning and qualification of a Sterile Formulation and Filling Facility. The job-holder works with the company Process Engineering Team to act as client owner representative to deliver integrated process engineering services to meet the Project Objectives. The Senior Process Engineer will manage cross functional teams to deliver a significant suite or multiple suites of related process scope.

 

Responsibilities:

  • Support GES Process Lead to implement a Process Design based on the scope of Process Requirements provided by the Technology and Manufacturing owners.
  • Lead cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables.
    • Ensure all project stakeholders are informed and consulted on key process suite activities and decisions.
    • Monitor progress of process suite team milestones with all team members and provide status reports to project Tiers and stakeholders.
  • Act as client owner representative to self-execute critical design deliverables and provide direction & oversee design progression by an Architect & Engineering design firm.
    • Develop Process Flow Diagrams, P&IDs, User Requirement Specifications and Equipment Specifications to ensure Process Descriptions/Needs are met.
    • Manage team to complete process safety deliverables including PHA (Hazops.)
    • Ensure the company’s Global and Carlow site engineering standards, procedures and practices are followed in the design development.
  • Support GES C&Q Lead to coordinate preparation and lead FATs/C&Q field execution.
    • Develop and/or review system lifecycle documents including Criticality and Risk assessments, FAT documentation, and C&Q documentation.
    • Manage installation / start-up / testing of process systems through OQ completion. Interface with cross-functional team to ensure systems’ post-OQ (PQ, PPQ) readiness.
  • Liaise with stakeholders, equipment vendors, business partners, and SMEs at other sites within the company Manufacturing Network as required to support Project.
  • On occasion, the job-holder may also undertake Project Engineering duties including:
    • Preparation of project related deliverables such as schedules, work plans, equipment cost tracking.
    • Coordination of project activities between stakeholders.

 

Minimum Qualifications and Experience:

  • Minimum qualification B.Sc. or M.Sc./ M.Eng Degree in Chemical or Biochemical Engineering or equivalent discipline; equivalent is defined as a Biotechnology or Industrial Chemistry Degree with basic the elements of chemical/biochemical engineering fundamentals as applied to sterile or aseptic manufacturing.
  • Minimum of 8 years post academic process engineering experience in relevant aseptic/sterile processing design, construction & start-up environment.
  • In depth understanding of process engineering and technologies pertinent to unit operations including Closed-Process Formulation, Depyrogenation Tunnel, Isolated Filling, Capping, Automated Parts Washing, Autoclave Sterilization, Mobile Process Vessels, Bioburden reduction/Sterile Filtration, and CIP/SIP.
  • Knowledge on the application of Disposable Technologies.
  • Knowledge of PLC process control platforms and industry SDLC methodology.
  • The role will require periods of travel to support vendor reviews & FATs, and periodic attendance at Architect & Engineering Firm offices (location TBD). Flexibility is required in this regard.

 

9429 - C&Q Senior Specialist - Cork

Purpose:

Reporting to C&Q Technical lead as part of a multi-discipline team responsible for Commissioning & Qualification (C&Q) activities on a Drug Product facility. The candidate will be a convincing communicator with strong interpersonal skills. This candidate will be required to work closely with a cross-functional team and coordinate activities between Construction, Process, Technical Operations, IPT and QA.

 

Responsibilities:

  • Report to C&Q Technical Lead on the project.
  • Support a suite team during a commissioning and qualification program.
  • Assist the C&Q Technical Lead in the planning and tracking of activities.
  • Liaise with the various stakeholders on the C&Q team and the overall project to ensure clear communication between all parties.
  • Participation in GMP design reviews (DQ, CIA etc), as required.
  • Review and Input into deliverables such as technical requirement specifications and vendor turnover documentation.
  • Participate in C&Q deliverables (System Impact Assessment, Critical Component Impact Assessments, System Boundary Drawings, Requirement Traceability Matrix).
  • Participate in generation, execution and approval of C&Q documentation (FAT, SAT, IOC, DQ, IQ, OQ, IOQ) for the project based on available approved client templates & design documentation.
  • Review of CCRs and TOPs. May require travel to vendor shops and frequent communication with vendors to ensure documentation deliverables are per the VDRs.
  • Participate in C&Q change controls (FDCNs and PCNs) and drive their closure in a timely manner. Ensure non-conformances & deviations are minimised and closed out in a timely fashion.
  • Responsibility for direct supervision of vendor engineers and contractors during C&Q activities.
  • Manage the site attendance for the vendors, contractors and specialist contractors.
  • Confirm all vendor documentation executions are compliant with GxP practices & the executed documentation is acceptable to support C&Q.
  • Perform system P&ID walkdown with construction prior to handover. Categorisation of punchlist items & tracking to completion.
  • Support review on all Isometrics, Weld logs, Weld Qualifications, 3rd Party Inspections, Material of Construction and Redlining exercise.
  • Confirm the site installation is as per approved design specification and meet system IQ requirements.
  • Facilitate/expedite Mechanical Completion in conjunction with the Construction team. (Liaise with construction contractors towards successful completion of Construction Turn Over Documentation).
  • Generate method statements, risk assessments & permit preparation for responsible areas from M/C to handover to site operations.
  • Pre-start up safety checks, LOTO & ensuring timely loop checking and calibrations.
  • Coordinate and supervise third party vendors during SAT execution. Review and approve SAT protocols.
  • Attend daily communication meetings with suite team and report progress.
  • Assist in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents.
  • Maintain a clean and safe working environment by enforcing procedures, policies, and regulations.

 

Minimum Qualifications and Experience:

  • Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
  • Minimum of 3 years’ experience in commissioning and/or validation of Drug Product Facilities/Utilities systems within Pharmaceutical industry.
  • Technical knowledge of black utilities and clean utilities systems and equipment, biotechnology processes and a working knowledge of FDA and EU regulations is preferred.
  • Previous experience working with the company will be advantageous
  • Experience in C&Q of Drug Product Facility
  • Working knowledge of process control systems and automation. DeltaV, syringe & vial line experience beneficial.
  • Knowledge of C&Q documentation required for cGMP process equipment.
  • Working knowledge of word processing, spreadsheets, database management software, CAD software, and PCs.
  • Knowledge of regulations and standards affecting devices, biologics and pharma products.
  • Knowledgeable with latest industry standards and guidelines on C&Q, including ISPE/ASTM
  • Implement company GES C&Q strategies as set out by the C&Q Technical Lead.
  • Ensure that system delivery progresses in accordance with the approved project schedule.
  • Notify C&Q Technical Lead, in a timely manner, of all relevant issues which may impact on system progress.
  • Ability to work in design and construction project environment within Ireland.
  • Coordinate with design and/or project teams to resolve any identified technical issues.
  • Organise/attend all coordination meetings necessary to progress the job.
  • Ensure that all works carried out in C&Q scope or responsibility by construction, commissioning and contract team members are performed in accordance with site safe working practices.

 

2019-281 - Project Engineer - Dublin

Purpose:

A vacancy exists for a P5 Project Engineer within the Technical Services Department. Reporting to Engineer Project Manager. You will be working within cross-functional teams with a high-level of autonomy; playing a key role in Schedule Preparation, Pre-Planning and Resource Forecasting along with Project Management of Opex and Capex Projects on site.

 

Responsibilities:

  • To lead projects taking the role of Engineering Team Leader, from project registration right through to validation/commissioning and hand over, as per Engineering SOP for ‘Project Management’ ensuring that projects are completed to specification, within budget and on programme.
  • To liaise with the project requester and define exactly the project brief.
  • To liaise with customer department as well as other Business Unit departments and support departments as required such as EHS, Tech Services, and Logistics etc.
  • To attend regular planning meetings as required to ensure plant downtime is agreed.
  • To make justifiable decisions at all times which will not compromise quality, capacity, flexibility, operability, security or EHS compliance.
  • To immediately report to the Engineer Project Manager any deviations from the project plan which would have an impact on quality, specification, programme or cost .
  • To ensure that adequate training is provided to Production and Engineering personnel, and to assist in any way that is practical.
  • Chairing of design review meetings, site meetings, haz-ops, project meetings etc.
  • To ensure that Project are handled and managed using the ’team’ approach.
  • Ensuring that the Engineer in particular and the Department as a team are kept up to date in current engineering technology and work practices by attending, with approval, relevant seminars, exhibitions, training/educational courses and by reading engineering literature.
  • To follow up snags ensuring that the project is completed fully, before closing the Capital Account.
  • To communicate effectively within the Department Function and particularly with the customer.
  • Ensure that all procedures described in the Department SOP’s or WI’s and Guidelines are strictly adhered to.
  • To ensure that plant hand over, including the preparation of documentation packages is carried out in a controlled and punctual manner as per company procedures.
  • To plan, manage, co-ordinate and design the ’front-end’ design of the project whilst evaluating quality and value relative to practicalities.
  • Preparation of equipment specifications, budget estimates, scope documents, IA submittals, purchase requisitions, cost control data sheets, meeting minutes and circulation of same.
  • To prepare installation specifications as per Standard Procedures and to complete AWP’s for all work.
  • To oversee and control CAD services to ensure drawings are registered, prepared, checked, approved, circulated and controlled as per SOP for ’Registration and Control of Engineering Drawings’.
  • To act as safety lead in line with construction regulations 2013 and appoint PSDP and / or PSCS as required. Also, to ensure EHS risk assessment carried out and actioned prior to capital submittal.
  • To liaise with appointed external consultancy practices as directed, ensuring that the consultant operates to company procedures within a team framework.
  • To source, select, procure, inspect, approve and oversee installation of equipment, machines and systems.
  • To ensure that current regulations, standards and work practices are adhered to for all project work, i.e. FDA, HSA, HPRA, EPA, British Standards, USP, ETCI etc.
  • For engineers managing direct impact projects they must carry out the commissioning and qualification phases as per SOP_002492.
  • To liaise with Q.A Compliance ensuring that regulatory and validation issues have been addressed in an approved manner.
  • To follow up on qualification deviations.
  • To manage and control contractors working on the company site, ensuring that work practices comply with the relevant sections of the 2013 Construction regulations, company Standards and cGMP.
  • To ensure decisions, work practices or use of certain contractors do not expose the company to the risk of an industrial dispute.
  • To ensure that training records are adequate and kept up to date.
  • Ensure that change control procedures are strictly adhered to.

 

Minimum Qualifications and Experience:

  • 3rd Level Qualification in an Engineering discipline.
  • For Engineers working on ‘Direct-Impact’ projects, they should have minimum 3 years pharma experience, and 5 years total experience.
  • For Engineers working on ‘Indirect – Impact’ projects, they should have minimum 5 years’ experience.
  • Sterile Processing – Bulk and Filling Operations.
  • Good understanding of sterility requirements/environmental monitoring requirements.
  • Grade A/B environment/exposure.
  • Good understanding of aseptic techniques and technology.
  • Cleaning Validation CIP/SIP (Stem in place.)
  • Media batch experience/incubation.
  • Understandings of Autoclave technology.
  • Strong documentation skills.
  • Good Understanding of Regulatory requirements.
  • Audit Experience.

 

2019-280 - Senior Project Engineer - Dublin

Purpose:

A vacancy exists for a P6 Senior Project Engineer within the Technical Services Department. You will be working within cross-functional teams with a high-level of autonomy; playing a key role in Schedule Preparation, Pre-Planning and Resource Forecasting along with Project Management of Opex and Capex Projects on site.

 

Responsibilities:

  • To lead projects taking the role of Engineering Team Leader, from project registration right through to validation/commissioning and hand over, as per Engineering SOP for ‘Project Management’ ensuring that projects are completed to specification, within budget and on programme.
  • Manage and co-ordinate the necessary resources to ensure effective execution of the design, costing, programming, installation and validation phases of all major capital projects.
  • Management of the annual CapEx plan and 5-year plan ensuring the correct funding is in line capacity / infrastructural requirements along with the site development plan. Contribute to the development of procedures for projects costing and programming. Plan annual budgets and monitor performance.
  • Following a project installation phase, implement the Plant hand back procedures by paying attention to engineering commissioning, check-lists and follow-up. Provide an Engineering C&Q function to the company.
  • Monitor contractors to ensure the company gets value for money and contractors are of the highest quality.
  • Initiation and preparation of project related plans, schedules, reports, feasibility studies, analysis, budget parameters. Prepare and maintain a regular project reporting format. Provide business cases, justifications and strategy input to major projects.
  • Ensure that the Project Department liaise effectively with all areas within Technical Services. Motivation of staff to ensure procedures and design is of the highest standard. Put in place performance measures in all areas to evaluate the effectiveness of the department. Establish goals and objectives for the department and review regularly.
  • Set up standards, codes of practice, procedures etc. for the department and the company as a whole, as required.
  • Pay due care and attention to Health and Safety and Environmental issues.
  • Ensure that all companywide procedures are adhered to within the Department and Ensure that all documentation is following the Engineering Department Standards.
  • Liaise with the Department customers ensuring that their requirements are fully understood and that their expectations are met.
  • Ensure that all staff and contractors receive adequate training in relevant areas and that training is reviewed on an annual basis.
  • Ensure that all work carried out is to the highest standard and is in accordance with international and regulatory standards.
  • To manage and organise effectively the Technical Services Department.
  • Deliver the Technical Services Department targets within budget and on time.
  • To provide strong leadership and coaching to all departmental personnel so that they actively support activities that improve performance.
  • To manage and organise resources within the Technical Services Department.
  • To put systems in place to continuously improve the Technical Services Department, identifying cost containment projects.
  • To lead the department with a proactive approach.

 

Minimum Qualifications and Experience:

  • Must have 3rd level Engineering qualification or equivalent Project Management/ Financial – Business qualification.
  • Minimum 10 years’ experience in the Pharma industry, preferably in a management / supervisory role.

 

9459 - Project Manager - Tipperary

Purpose:

A vacancy exists within our Global Engineering Solutions (GES) group for a Client Side Project Engineer / Construction Manager supporting GES capital projects in Tipperary. The successful candidate will have several years’ experience working in the pharmaceutical or similar Industry. Reporting to the GES Project Manager based at the Tipperary Site. The Engineer will be a key member of the project management team on a $100MM capital project. The Engineer may also work on other projects as needed by the business. The successful candidate will be able to demonstrate a proven track record to lead project delivery efforts and to influence others, be a convincing communicator with strong interpersonal skills and strategic and tactical thinking abilities. Have knowledge of Cleanroom/HVAC/E&I, equipment and utilities systems.

 

Responsibilities:

  • Ensure there is a strong safety culture and performance in the field execution of project deliverables and that appropriate stage gate controls are in place for all works, coaches project team wrt to safety , is involved in any investigations (near miss etc.)
  • Works closely with CM from EPCM to develop construction team.
  • Attends field walk downs as client CM Representative to ensure that appropriate standards are being met with installations.
  • Completes early walk downs on systems and works with overall construction team to resolve punch lists based on priorities.
  • For construction acts as an interface with Tipperary site to address and resolve any conflicts.
  • Attends and provides inputs to Interactive Pull Planning Workshops with appointed contractors and other stakeholders to plan out construction and energisation activities in a schedule critical project, identifies any constraints and works to remove these and other barriers.
  • Ensure that Lean Construction Tools and Methodologies are being implemented in the field (Tacht, Last Planner & Pull Plan Scheduling, Target Value Design and Construction, Integrated Project Safety Team Structure, Right First Time approach.)
  • Ensures that EPCM has appropriate stage gate approach in place to ensure rigour in allowing systems pass from Testing – Construction Completion – Energisation.
  • Ensure Project Quality Standards are implemented and that documentation requirements met.
  • Coordinate the project construction programme, incorporating
    • Enabling CSA works, Main CSA Works, cleanroom, Clean & Black Utilities generation/ Distribution, Process Equipment Installation, office and warehouse fit out.
  • Attends daily tier meetings / weekly co-ordination meetings regarding construction.
  • Reviews and approves any site field instructions and manages commercial contract variations with EPCM, acts as a delegate for the Project Manager.
  • Completes daily walkthrough of site for safety and checks on progress etc.
  • Manage project changes in construction and ensure all are captured, documented and assessed for Quality / Safety / Cost or schedule impacts.
  • Assist with the coordination of design, construction, commissioning and qualification, schedule and cost in collaboration with other project team members, company personnel, outside contractors and vendors.
  • Track and report construction progress as required against project deliverables.

 

Minimum Qualifications and Experience:

  • Must have as a minimum a 3rd level Degree in a relevant discipline.
  • A minimum of 10 years+ of relevant experience in capital projects preferably in Pharm/Bio Pharm.
  • Proven level of experience in delivering significant capital projects within the pharmaceutical sector > €80MM.
  • Ability to sequence critical activities in planning work for construction phase.
  • Ability to coordinate activities to deliver projects to an aggressive schedule.
  • Knowledge of clean room installation an Advantage.
  • Understands the typical project life cycle from concept through to qualification and has proven experience in this area.
  • Proven knowledge, appreciation and experience of working with Lean Construction Tools and Methodologies.
  • Demonstrated achievements within multi-functional teams.

 

9035 - Project Manager - Tipperary

Purpose:

A vacancy exists within our Global Engineering Solutions (GES) group for a Senior Project Engineer supporting GES capital projects in Tipperary. Reporting to the Global Engineering Solutions Project Manager based at the Tipperary Site. This will be a key role in the GES organization which is currently executing significant Sterile, Pharmaceutical and Chem API projects. The Project Engineer will be a key member of the project management team on a 100MM capital project. The successful candidate will be able to demonstrate a proven track record to lead project delivery efforts and to influence others, be a convincing communicator with strong interpersonal skills and strategic and tactical thinking abilities. Have knowledge of Cleanroom/HVAC/E&I, equipment and utilities systems.

 

Responsibilities:

  • Assist in the development of project plans and successfully execute them according to established schedule, cost and performance standards.
  • Work closely with EPCM to effectively & efficiently progress the clean utilities, black utilities & cleanroom design.
  • Manage design, construction, commissioning and qualification, schedule and cost in collaboration with other project team members, company personnel, outside contractors and suppliers.
  • Track and report progress as required against project deliverables.
  • Ensure there is a strong safety culture and performance in the execution of capital projects
  • Monitor progress of project milestones with all team members and provide status reports. that all project stakeholders are informed and consulted on key project activities, progress and decisions.
  • Develop and maintain appropriate electronic and paper documentation & filing systems to ensure that all project documents are filed during project execution and safely archived following project completion.
  • Ensures that good Engineering practices are utilised and aligned with customer’s needs from requirements gathering, through design and execution.
  • Manage project changes and ensure all are captured, documented and assessed.
  • Manage the execution of Commissioning & Qualification documentation.
  • Manage a change control procedure to the assigned scope
  • Participate in EPCMv led HAZOP and design reviews as lead GES
  • Representative, ensuring company stakeholder inputs are coordinated and appropriate.

 

Minimum Qualifications and Experience:

  • A minimum of 8 years of relevant experience in project management of capital projects in a high tech industry, preferably in Pharm/Bio Pharm.
  • Must have as a minimum a 3rd level Degree in Engineering, preferably Chemical or Mechanical
  • Preferable to have a qualification in project management – PMP or equivalent
  • Proven level of experience in delivering significant capital projects within the pharmaceutical sector.
  • Ability to sequence critical activities in planning work for.
  • Ability to coordinate activities to deliver projects to an aggressive schedule
  • Knowledge of clean room installation an Advantage
  • Understands the typical project life cycle from concept through to qualification and has proven experience in this area.
  • Familiar with engineering project management tools, financial management skills including an ability to work within budgets, and engineering technical skills.
  • Proven knowledge, appreciation and experience of working in strongly regulated GMP environment
  • Strong interpersonal skills and an understanding of the customer/client relationship involved in projects
  • Demonstrated performance and managing multi-functional teams.
  • Demonstrated experience in leading projects from Design to Qualification.

 

9493 - Process Support Specialist - Carlow

Purpose:

Responsible for generating and expediting review and approval processes for IPT GMP documentation including but not limited to Quality Notifications, CAPA close out records, IPT Standard Operating Procedures and Standard Work Instructions and change controls. Ensure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety and reliable supply to our customers.

 

Responsibilities:

  • Support manufacturing activities through documentation generation, equipment and process investigations associated with non-GMP activities and completion of quality notifications. Provide input to the MES development process team on technical aspects of MES functionality and serve as MES SME within IPT.
  • Be a document system expert; this will include document review, approval and document system work flow expedition. Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOP’s, SWI’s, training documents, and change controls.
  • Support operation activities through documentation generation, filing, tracking, auditing and efficient maintenance of all associated databases including the maintenance, auditing and archiving of the process documentation system.
  • Support Batch release through timely Quality Notification completion, Interim/summary report generation; meeting batch release requirements.
  • Raise CAPA’s and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system.
  • Complete Customer complaint investigations and Change Controls and ensure they are closed out to support production activities in a timely manner in conjunction with the SCM team.
  • Required to comply with company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
  • Work collaboratively to drive a safe and compliant culture in Carlow.
  • May be required to perform other duties as assigned.
  • Assist in the management and/or assignment of IPT training if required.

 

Minimum Qualifications and Experience:

  • Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
  • Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably GMP setting.
  • SAP knowledge and experience required.
  • Proficiency in Microsoft Office and job related computer applications required.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Report, standards, policy writing skills required.
  • Equipment and process validation.
  • Sterile filling processes and equipment.
  • Lean Six Sigma Methodology experience desired.
  • Understand the specific responsibilities of all Carlow departments as they relate to ones own department, understanding the business processes ones department supports.
  • Excellent training, facilitation and assessment skills.
  • Risk management skills.
  • Strategy planning and development.
  • Demonstrable analytical and systematic problem-solving skills.
  • Strong influencing skills.
  • Flexible approach.
  • Focus on Customers and Patients.

 

2019-276 - QA Specialist - Waterford City

Purpose:

Reporting directly to the Quality Assurance Team Leader, as a critical leader for the company, you will play an integral role in providing day to day Quality and compliance support to the sterile manufacturing operations.

Responsibilities:

  • Working as part of the Quality Assurance team on site ensuring products are manufactured, stored and packaged in accordance with cGMP
  • Implement and support a batch release system in the QA function of Sterile Manufacturing
  • Support the development of GMP training packages and delivery of training
  • Participate in the preparation and review of procedures and batch documentation
  • Review and approval of deviation, CAPA’s, quality events and tasks
  • Ensure the quality system at the company is effectively implemented and maintained
  • Acts as Quality Point person for systems / processes providing guidance / feedback on quality issues
  • Perform timely review of documentation / investigations / reports highlighting and assisting in the resolution of concerns commensurate with the risk
  • Work with relevant departments to ensure timely closure of quality actions / findings
  • Actively contribute to continuous improvement initiatives
  • Conduct duties in a safe manner and report all safety issues or concerns

 

Minimum Qualifications and Experience:

  • Bachelor’s degree in a science related subject is essential
  • 3 years experience in a manufacturing environment, sterile experience is preferable
  • Effective technical knowledge of sterile manufacturing processes
  • Operational experience of quality systems in a dynamic manufacturing environment
  • Knowledge of requirements for cGMP, US and EU regulatory requirements
  • Full understanding of relevant quality and compliance regulations
  • Able to manage projects to plan/budget
  • Effective facilitator
  • Understands KPI’s for the team and site
  • Must be able to respond quickly to unplanned events, technical issues and changing needs from development programs
  • All applicants must be open to shift work

 

2019-272 - Head Microbiologist - Waterford City

Purpose:

The Head Microbiologist manage all aspects of the QC Microbiology Department function across both of the company’s plants: including to develop, manage and maintain control systems; and oversee department performance. Responsible for the microbiological environmental monitoring program and analysis of materials as required.

 

Responsibilities:

  • Management of personnel regarding reviews, time management, development, training and qualification.
  • Schedule resources and activities to meet timelines
  • Ensure compliance to cGMP, safety and company policies.
  • Manage reports required for compliance activities and effective management of labs, e.g. monthly reports, development protocols/reports, validation reports etc.
  • Management of laboratory equipment including, Qualification, e.g. IQ/OQ, calibration and maintenance.
  • Administer and manage investigations as required e.g. deviations, alarms, 00S etc.
  • Review and access results and develop appropriate action strategies
  • Set targets and objectives for the effective microbiological control of facility
  • Carry out all activities in compliance with company Safety & Environmental Standard Operating Procedures.
  • Observe the safety rules and personal protective equipment requirements of all areas entered
  • Participate in team based project work and plant-wide initiatives to improve the GMP compliance and financial performance.
  • Manage & develop Quality Control systems
  • Approve procedures for the Quality control activities such as SOPs, specifications, test methods, calibration assessments etc.
  • Maintain, develop and manage QC microbiology laboratory to cGMPs
  • Ensuring all follow Standard Operating Procedures while carrying out duties at all times.
  • Participate fully in all GMP and operational training programs and complete all Training Records in an accurate and timely manner.
  • Management of personnel assigned to QC Microbiology Laboratory.

 

Minimum Qualifications and Experience:

  • Degree level Qualification
  • A min of 5 years’ experience in a regulated medical devise or pharmaceutical environment
  • Experience in Microbiological techniques such as: bioburden analysis, water analysis, environmental monitoring, endotoxin, sterility, media quality control and identification
  • Experience in Method validation and method transfer
  • Experience of scientific report writing including such documents as SOP’s, protocols, deviations, reports etc.
  • Ability to evaluate and access information to determine appropriate risk and required actions is critical
  • Familiarity and understanding of pharmacopeia requirements for pharmaceuticals
  • Familiarity and understanding of FDA and EU requirements for finished pharmaceuticals

 

2019-274 - Senior Quality Engineer - Waterford City

Purpose:

The Senior Quality Engineer is instrumental in providing support to ensure R&D projects and New Product Set Ups are managed effectively from a Quality Perspective. The Senior Quality Engineer will ensure that the company’s Quality management system is adhered to at all times, and that directives, policies and procedures are complied with.

 

Responsibilities:

  • Work Closely with R&D during the development and introduction of new products and technologies.
  • Work with the R&D Team to ensure that all Quality Control Requirements for new products and technologies are defined and understood and that they are transferable and maintainable in a production environment.
  • Lead failure analysis PFMEA, to ensure functional specification requirements are fully met during validation.
  • Provide validation support by approval of validation documentation associated with new product validations and technologies.
  • Technically understand the process in question and provide input to, development protocols, process validation protocols, inspections and analysis of results.
  • Ensure agreement on acceptance criteria. Work with the Project Team to achieve a robust validated process that is in compliance with regulatory requirements and Global Requirements.
  • Ensure that validation product is properly controlled, segregated and identified.
  • Track, trend and report on Quality performance of new product introductions and technologies post validation.
  • Drive the resolution, analysis and problem solving of new product related issues, working closely with both manufacturing Quality and R&D.
  • Lead CAPA/Nonconformance activity when required.
  • Ensure the efficient and timely transfer of Quality knowledge to manufacturing quality engineers and coordinate the training of quality engineers and quality technicians on new quality systems and equipment and products. Ensure all appropriate documentation is in place prior to production start.
  • Ensure all cGMP are followed at all times and maintain good documentation protocol for work instructions , SOP’S and Forms.

 

Minimum Qualifications and Experience:

  • Third level Qualifications in Science or Engineering
  • Minimum 3-5 years’ experience in a regulated pharmaceutical/medical device with at least 2 years in a senior Quality Role essential.
  • Full understanding and experience of the requirements of ISO 13485, 21 CFR Part 820 and Part 11.
  • Understanding of data integrity requirements.
  • Experience in providing Quality Support for Product Development and validation beneficial.
  • Must have the ability to analyse and provide Quality Direction on product/equipment issues using independent judgement.
  • Statistics/Six Sigma Qualification Beneficial.

 

2019-273 - Desktop Support Engineer - Waterford City

Purpose:

The Desktop Support Engineer will support the Infrastructure & Database Lead for office and manufacturing based end user computing hardware and software on PCs, laptops, mobile devices, printers and peripherals. These systems will support the Manufacturing Environment of the Plants in Waterford.

 

Responsibilities:

  • Responsible, as part of a team, for providing support to a large number of computing devices and users.
  • The primary helpdesk agent providing multi-level support to the site.
  • May be required to provide out of hours support on a Rota basis to the plant for critical systems and services.
  • Installation and support of various software applications.
  • Liaise with vendors on installation and error resolution.

 

Minimum Qualifications and Experience:

  • Third level Qualifications, coursework and experience supporting listed key activities of this position is advantageous.
  • Previous experience in regulated manufacturing environment advantageous.
  • Excellent troubleshooting skills.
  • High proficiency in installing and troubleshooting Windows 7 to 10.
  • An Awareness of enterprise systems and software such as SCCM, GPO, AD, DNS, DHCP, Bitlocker, WSUS patching, Networking, backups, helpdesk system, firewalls, proxy, Outlook etc.
  • Some system admin scripting experience.
  • Knowledge of backup software.
  • Ability to take on small projects.
  • Level qualification in Computer Science is preferred.
  • Good practical understanding of computer networking.
  • A keen eye on technology, able to bring new ideas and suggestions to the IT team.

 

9384 - Senior Process Engineer - Cork

Purpose:

Provide process engineering services in support of the design, construction, commissioning and qualification of a new vial filling line. The job-holder works with the company’s Process Engineering Team to act as client owner representative to deliver integrated process engineering services to meet the Project Objectives. The Process Engineer will lead the delivery of a vial wash / tunnel / filler equipment package and will be a key member of a wider team focused on the retrofit of an existing sterile manufacturing facility for a new product.

 

Responsibilities:

  • Support GES Process Lead to implement a Process Design based on the scope of Process Requirements provided by the company Technology Transfer and Process Development Groups.
  • Lead cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables.
    • Ensure all project stakeholders are informed and consulted on key process suite activities and decisions.
    • Ensure team is delivering to plan against project milestones and provide status reports to project Tiers and stakeholders.
    • Escalate issues, constraints and risks as required
  • Act as client owner representative to self-execute critical design deliverables and provide direction and oversight of design progression by an Architect & Engineering design firm.
    • Ensure IFC Process Flow Diagrams, P&IDs meet process needs.
    • Lead vendor management and equipment testing to verify User Requirement Specifications and Equipment Specifications are met.
    • Manage closeout of process safety deliverables including PHA (Hazops) and machine safety checklists.
    • Ensure company Global and Cork site engineering standards, procedures and practices are followed.
  • Support GES C&Q Lead to coordinate preparation and lead FATs/C&Q field execution.
    • Review and approve system lifecycle documents including Criticality and Risk assessments, FAT documentation, C&Q documentation.
    • Manage installation / start-up / testing of process systems through OQ completion. Interface with cross-functional team to ensure systems’ post-OQ (PQ, PPQ) readiness.
  • Liaise with stakeholders, equipment vendors, business partners, and SMEs at other sites within the company Manufacturing Network as required to support Project.
  • On occasion, the job-holder may also undertake Project Engineering duties including:
    • Preparation of project related deliverables such as schedules, work plans, equipment cost tracking
    • Coordination of project activities between stakeholders

 

Minimum Qualifications and Experience:

  • Minimum qualification B.Sc. or M.Sc./ M.Eng Degree in Engineering, preferably Chemical or Biochemical Engineering or equivalent discipline; equivalent is defined as a Biotechnology or Industrial Chemistry Degree with basic the elements of chemical/biochemical engineering fundamentals as applied to biotechnology/bioprocessing
  • Minimum of 5 years post academic process engineering experience in a biopharmaceutical processing design, construction & start-up environment
  • Demonstrated ability to lead / influence teams in matrix environment
  • Excellent communication/presentation/organizational skills
  • In depth understanding of process engineering and technologies pertinent to unit operations including sterile filling.
  • Knowledge on the application of Disposable Technologies
  • Knowledge of PLC process control platforms and industry SDLC methodology
  • The role will require periods of travel. Flexibility is required in this regard.

 

9393 - CSV Engineer - Carlow

Purpose:

Reporting to the facilities AIT CSV Lead, specifically responsible for Computer System Validation (CSV). The CSV engineer will be responsible for the development of key AIT quality documents, such as Quality Assurance (QAPs) and test plans, and for ensuing adherence to the QAPs. This candidate will be required to work closely with the facilities AIT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.

 

Responsibilities:

  • Develop and maintain Qualification Plans and Test Plans, aligned with the overall project C&Q plan and with the leveraging strategy.
  • Develop templates for all SDLC deliverables, compliant with company standards, to ensure consistent implementation of the validation strategy, including but not limited to:
  • Requirements Specification
  • Requirements Traceability Matrix
  • Functional Specification
  • Design Specification
  • Code Review
  • Test specification/test script
  • ETC
  • Work closely with the QAIT function and ensure their requirements are met in all deliverables
  • Align with the company HPV program: leverage existing documents & expertise where feasible
  • Approver of all AIT SDLC deliverables, ensuring compliance with standards
  • Provide FAT oversight and perform leveraging assessments,
  • Provide guidance and support to AIT team members tasked with delivery of SDLC documents
  • Provide input to the development of realistic project schedules and document trackers
  • Work closely with suppliers / integrators to ensure compliance with company standards
  • Participate in, and support, relevant project meetings
  • Liaise with the various stakeholders on the overall project to ensure clear communication between all parties in relation to AIT validation requirements.

 

Minimum Qualifications and Experience:

  • Relevant Computer Science or Engineering degree or equivalent
  • Minimum of 3 years’ experience in a similar role, ideally in the Pharmaceutical industry.
  • Expert knowledge of GAMP5.
  • Strong experience in one or all of the following systems: DeltaV, PCS7 (or other PLC/SCADA), OSI PI.
  • Usual place of work will be in the company’s Carlow facility. The successful candidate may sometimes be required to attend meetings at other company sites or off-site.
  • Previous experience working with the company will be advantageous.

 

9392 - Senior Automation Engineer - Carlow

Purpose:

Reporting to the facilities AIT OEM Lead, specifically responsible for OEM Systems. This candidate will be required to work closely with the facilities AIT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.

 

Responsibilities:

  • Develop and/or review SDLC deliverables, compliant with company standards, including but not limited to:
  • Requirements Specifications
  • Requirements Traceability Matrix
  • Functional Specification
  • Design Specification
  • Code Review
  • Test specification/test script

 

  • Work closely with vendors of OEM equipment to ensure deliverables meet project requirements, including the interfacing of new OEM equipment with existing site systems, incl. MES and Pi Historian.
  • Work closely with the QAIT function and ensure their requirements are met in all deliverables.
  • Participate in Hardware and Software FATs and SATs.
  • Provide input to the development of project schedules and document trackers.
  • Participate in, and support, relevant project meetings.
  • Liaise with stakeholders on the overall project to ensure clear communication between all parties.
  • Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.

 

Minimum Qualifications and Experience:

  • Relevant Computer Science or Engineering degree or equivalent
  • Minimum of 3 years’ experience in a similar role, ideally in the Pharmaceutical industry.
  • Strong experience in one or all of the following systems: Siemens PLCs, HMIs and Historian Software.
  • Usual place of work will be in our client’s Carlow facility. The successful candidate may sometimes be required to attend meetings at other company sites or off-site.
  • Previous experience working with the company will be advantageous.

 

9386404 - Quality Assurance Specialist IV - Dublin

Responsibilities:

  • Use deep process knowledge and experience to assist business partners with the creation, review, approval and closure of deviations, investigations, CAPAs, change controls and associated quality risk assessments in compliance with internal and external requirements.
  • Proactively identify opportunities and support continuous improvement of enterprise QMS processes and associated systems.
  • On-time completion of assigned projects.
  • Monitor QMS process performance to identify trends and best practices on an ongoing basis (audits, visual management systems, dashboards, status reports etc.).
  • Author, review and approve of QMS procedural documentation and work instructions.
  • Create and deliver Quality Systems training (process and technical).
  • Compile, analyze and present QMS monthly and quarterly metrics at Quality Management Review.
  • System user access management.
  • Participate in inspection readiness activities and internal/external audits and inspections.
  • Other duties required to support the growing Quality organization as assigned.

 

Minimum Qualifications and Experience:

  • Bachelor’s degree in a technical or life sciences discipline (ex. Chemistry, Biology, Biotechnology)
  • 5 years’ + QA experience within the pharmaceutical industry or related field.
  • Significant, direct experience with development and approval of a minimum of two of the following: Deviations, CAPAs, Change Controls and quality risk assessments.
  • In-depth knowledge of global cGxP requirements for quality systems.
  • Experience working with stakeholders in pre-commercial, manufacturing, laboratory and distribution functions.
  • Excellent communication skills with all levels of the organization and Health Authority representatives.
  • Demonstrated critical thinking and problem solving skills.
  • High level of organization and attention to detail to plan, execute and track completion of deliverables.
  • Able to prioritize and manage workload and manage shifting priorities based on criticality to ensure commitments are met.
  • Knowledge of medical device quality system requirements desired.
  • Direct experience with TrackWise desired.
  • Project Management and Lean Six Sigma certifications a plus.
  • Qualified Person designation a plus.

 

9377 - Compliance Specialist - Cork

Purpose:

To implement, audit and advice on company EHS policy to ensure the safe operation of the Vaccine IPT and the health and safety of its employees and the prevention of any environmental excursions or notices of violation. To promote EHS management systems, business continuity, regulatory compliance, community, company image/reputation and performance within Vaccine IPT, promoting alignment with global EHS strategies and objectives. The Specialist, Safety & Environment is accountable for the smooth execution of all appropriate functions associated with EHS within the Vaccine IPT. The Specialist, Safety & Environment will participate and comply with the Global Safety and Environment Management System and the MMD Quality Management System (QMS) requirements, including ownership, as relevant.

 

Responsibilities:

  • Supports Corporate and Vaccine IPT EHS strategy and objectives, contributes to development and implementation of global EHS programs and promotes local alignment with same.
  • Promotes culture of EHS excellence at facility and provides high-quality safety, health and welfare technical leadership to the Vaccine IPT.
  • Addresses risk prevention opportunities including hazardous materials exposure, spills, releases, accidents, fires, or other unsafe conditions.
  • Manages EHS risk profile for the Vaccine IPT.
  • Optimizes existing operations and practices with focus on continuous improvement initiatives.
  • Provides oversight on EHS projects for the Vaccine IPT.
  • Conducts annual self-assessments, and more frequent EHS audits, tracking and directing follow-up activities to correct any non-conformity.
  • Creates and maintains databases & records containing pertinent EHS metrics and data.

 

Minimum Qualifications and Experience:

  • 3rd Level degree in EHS, chemical engineering or other related discipline (chemistry, physical sciences or biology) is required. (Other 4-year degree health/sciences with significant equivalent work experience in EHS field may suffice.) Graduate degree preferred.
  • Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Manufacturing, Quality, Engineering, Tech Services etc).
  • Typically will have experience in EHS and/or engineering related positions, including knowledge of chemical, pharmaceutical, research and development processes is desired.
  • Knowledge of and experience in applying Lean Six Sigma and Lean methodologies (e.g. 6S)
  • Typically will have experience in EHS and/or engineering related positions, including knowledge of chemical, pharmaceutical, research and development processes is desired.
  • Professional certifications in related disciplines and/or advanced degree in EHS management are a plus
  • Evidence of Continuous Professional Development.
  • Six Sigma Green Belt
  • Working cross-functionally, identifies EHS problems and provides possible alternatives and solutions
  • Provides technical expertise in investigation of problems and develops innovative solutions, implementing corrective and preventive action plans to address problems.
  • Handles ambiguous and complex issues as they arise. Initiates and takes responsibility for his/her own professional development.
  • Position may directly or indirectly supervise others.
  • As applicable, trains, develops, and coaches staff as well as monitors their output and performance
  • Leads cross-functional projects and initiatives as assigned.

 

9060112 - Investigation Specialist - Dublin

Purpose:

This position is responsible for conducting and documenting investigations associated with the company’s Quality Control Laboratory – Laboratory Investigation Reports (LIRs) and deviations. In this role, you should have excellent investigational, root cause analysis and problem-solving skills. Relationship building, a high attention to detail and excellent verbal and written communications skills are vital to success in the role

 

Responsibilities:

  • Conduct and document investigations associated with the company’s Quality Control Laboratory in a complaint and timely manner.
  • Conduct root cause analysis.
  • Develop and document Corrective and Preventative Actions (CAPAs) and associated CAPA Effectiveness Checks (EC).
  • Track and trend investigations and associated root cause types.
  • Provide training and mentoring for Laboratory Staff.
  • Identify process improvements within the function and drive the initiative forward to implementation and effectivity
  • Comply with internal SOP’s, standards and associated training .
  • Support the Quality Control, with responsibility to develop processes.
  • Responsible for assigned LIR, CAPA’s, Change Controls & Deviations program and initiate Corrective Action plans in the company’s Quality Management System, TrackWise.
  • Maintain regular and proactive communication with all stakeholders

 

Minimum Qualifications and Experience:

  • At least 5 years’ working in Pharmaceutical quality operations
  • Degree in science/pharmaceutical related subject
  • Knowledge and understanding of GMP standards
  • Strong problem solving experience
  • Familiar with continuous improvement initiatives
  • High level of experience of conducting Laboratory Investigations, root cause analysis and CAPA development.
  • Highly Computer literate, with MS Office (Word, Excel)
  • Experience of provision training to others
  • Experience of working in a GMP Quality Control Laboratory or Quality Assurance Unit

 

8614 - Project Engineer - Carlow

Purpose:

This role is to lead and manage multiple Technical Engineering projects needed to support the business at Carlow. This includes but is not limited to: Process improvements, capital projects and Lean projects across multi-disciplined functions which may also require global and network support and collaboration.

 

Responsibilities:

  • Manage projects at Carlow from scope development, design, build/install and qualify through to handover to operations for key Technical Engineering projects at Carlow. Use scientific, product and process understanding as a basis for developing risk based approaches to investigations and trouble shooting that will feed into future projects.
  • Develop project scope, cost and delivery time schedule for all Tech Eng projects, working and collaborating closely with Technical engineering leads to ensure integration into ongoing Validations and/or Technical transfers. Collaborating closely with cross functional teams to establish scope in improvement projects at Carlow.
  • Act as a subject matter expert on: equipment design and qualification; assisting in C&Q execution planning; system boundary definition, system level and component criticality impact assessments, use of quality risk management, User Requirement Specs. and requirements traceability matrices, Document Mgt. Systems, FAT/SAT and C&Q protocol development, project implementation.
  • Sponsor and foster lean six sigma and standard work within the technical engineering Team (e.g. Structured Root Cause Analysis, Statistical Process Control, Data driven decision making).
  • Drive and support continuous improvement by active participation in projects, system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate. Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system.
  • Integration of Computer Systems Validation activities, in collaboration with Automation/IT partners, into required projects
  • Lead and assist in the development and coaching of Technical Engineering personnel whilst delivering to the site business needs.
  • Drive collaboration between groups within the Technical Engineering function proactively looking for synergies and innovative ways of doing work. Constantly assessing our systems and processes to see what improvement we can make to work smarter and more efficiently while all the time being compliant.
  • Act as a liaison with both global engineering services and facilities as well as specialist vendors to deliver projects on time and in full as required by the business.
  • Required to comply with company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
  • Work collaboratively to drive a safe and compliant culture in Carlow. Collaborate with multiple partners (eg. company network groups, third parties, vendors, quality, donor sites, Supply chain, IPT) in achieving excellence in technical transfer programmes. Serve as technical engineering representative for internal technical group discussions and represent Technical Engineering Carlow at Global Technical Forums as required.
  • May be required to perform other duties as assigned.

 

Minimum Qualifications and Experience:

  • Bachelor Degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline
  • Green Belt preferable
  • Considerable experience in a comparable role; would typically have experience operating as a senior professional and adding considerable value to the business. Would have process engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team of engineers / scientists through sustaining operations and technical transfer projects. Experience in leading through change would be an advantage.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
  • In depth knowledge and experience of Sterile filling processes and equipment especially aseptic processing
  • Experience of executing and/or managing through equipment and process design and validation in a sterile environment
  • Good shipping/Filter/Cleaning validation knowledge required
  • Knowledge of QbD/CPV desirable
  • Excellent report, standards, policy writing skills required
  • Automation and MES knowledge
  • Lean Six Sigma Methodology experience desired
  • Experience in audit preparation and execution desired
  • Have proven record of process improvement implementation
  • Have a proven record of project management of change in a commercial site
  • Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner Understand the specific responsibilities of all Carlow functions as they relate to one’s own department as well as the network governance groups
  • Excellent people management skills
  • Proven record in planning and basic project management of a team to deliver on time/schedule and cost
  • Proven contractor and vendor management
  • Have shown the ability to effectively manage complex projects across multiple disciplines
  • Demonstrate analytical and systematic problem solving skills
  • Strong change management skills
  • Business acumen
  • Strategy planning and development
  • Risk management skills
  • Excellent facilitation and assessment skills
  • Have shown the ability to manage budgets and forecasts and use a formal capital management process

 

9117 - Project Manager - Cork

Purpose:

The Project Manager will provide project management expertise to the company’s Cork site which manufactures quality pharmaceutical products in accordance with the company priorities of: Compliance, Supply, Strategy and Profit Plan. This individual will be a part of a newly formed Project Management Office (PMO), its goal being to ensure the site delivers on its key strategic projects and initiatives. The projects fall into, but are not limited to, the following categories: Data Integrity, Technical Transfers, Business Transformation, Engineering Projects, Supply Chain & Quality, Site Continuous Improvement Initiatives. The working style of the PMO team is one of collaboration, coaching and facilitation in providing project management support in a High-Performing Organization. This role will require a substantial amount of time within the project management process, engaging and communicating with Project Leads and team members.

 

Responsibilities:

  • Responsible for project oversight and control activities, including definition of scope, business case development, requirements & milestone identification, project governance, operational planning, risk identification & mitigation, implementation planning, project execution oversight and project closure.
  • Responsible for the creation and control of project plans for departmental, cross departmental, and company-wide projects.
  • Responsible for ensuring that projects are delivered on time, to an agreed level of quality and within approved budget and scope.
  • Delivery of effective & accurate project progress reports that can be analysed and understood at all levels within the organization.
  • Responsible for project stakeholder management, both internal and external, to ensure effective delivery of project objectives, including escalation management.
  • Responsible for identification of project risks and issues and the implementation of mitigating actions.
  • Oversight & control of project cost management throughout the project life cycle, and continually providing sound financial stewardship and control.
  • Motivating a multi-disciplinary team to achieve project objectives, by driving the teams’ performance so that every individual understands their contribution to the project and how it impacts the achievement of the site’s objectives.
  • Providing on-going coaching to Project Leads and team members, including the identification and development of key talent and skills within the site.
  • Supporting other site Project Managers to develop standard reporting templates and KPIs.
  • Ensuring there is a strong safety culture and performance in the execution of projects.
  • Ensuring the highest Quality & Compliance standards, participating and complying with the company Quality Management System.
  • Support the development and running of the Project Management Office on site.
  • Responsible for supporting a culture of Continuous Improvement by deploying company Lean Six Sigma tools

 

Minimum Qualifications and Experience:

  • Appropriate 3rd level qualification
  • Appropriate project management qualification.
  • Evidence of Continuous Professional Development
  • A minimum of eight to ten years of relevant experience in the delivery of a broad range of projects, preferably in the pharmaceutical industry.
  • Knowledge of and experience in applying Project Management tools and techniques with a wide spectrum of Project Leads and team members.
  • Demonstrated leadership & coaching skills, with an emphasis on continuous improvement of the PM process and skill sets of Project Leads and team members.
  • Demonstrated ability in holding project team members responsible for results and being decisive about non-performers
  • Demonstrated successes in a team environment, such as project teams, Six Sigma teams, PITs etc.
  • Demonstrated high level of problem solving and facilitation skills. Stakeholder management of multi decision makers, colleagues, peers and cross functional teams
  • Understands the typical project life cycle from concept through to qualification in a strongly regulated GMP environments and has significant proven experience in this area
  • Demonstrated leadership skills necessary to build and maintain high performance project management teams
  • Experience with Management Systems such as PM, EHS, Trackwise, SAP , PRINCE, Microsoft PM etc.

 

8917 - CAD Designer - Cork

Purpose:

This role will be to provide support to the existing Cork Drawing Office and Engineering Project teams in the preparation of CAD drawings. As an integral part of a design team you will be responsible for developing new drawings, amending existing drawings to reflect as built conditions in the field. Candidates should be motivated and enthusiastic, have the ability to work on their own initiative and be able to meet deadlines and liaise successfully with clients.

 

Responsibilities:

  • Produce and amend drawings in line with the site Drawing Management System.
  • Participate in all activities within the drawing office. Ensure that all architectural, electrical, mechanical, civil, instrumentation, general layout drawings are at the correct revision.
  • Ensure that all change management updates are captured and reflected on the appropriate drawings.
  • Ensure that drawing documentation packages issued from projects are correct and are in line with site standards.
  • Ensure compliance for all drawings and procedures that fall under the responsibility of the company.
  • Assist with the development of draughting and documentation staff as required.
  • Ensure all drawings are stored correctly in electronic and paper format and that all drawings issued and received by the department.
  • Carrying as built surveys of existing P&ID drawings and ensure current drawings reflect the as built site conditions.
  • Work closely with the Drawing Office Manager and Engineering Project Teams to develop solutions.
  • Ensure all activities are carried out in line with Company QA & EHS Requirements and Procedures.
  • Play an active role in the CAD Standards/Standard Operating Procedures input.

 

Minimum Qualifications and Experience:

  • Minimum of Higher National Diploma or Higher National Certificate qualification in Engineering
  • 5+ Yrs Industry Experience with 3+ Yrs working in a similar role.
  • Minimum of 5 Yrs Experience with using AutoCad.
  • Interact with above site personnel to understand changes and promote the site.
  • Solid engineering acumen.
  • Demonstrated capability to communicate effectively across multiple teams
  • Good knowledge of GMP / FDA regulatory requirements and current Health and Safety Regulations legislation.
  • Experience with 3D modelling software packages would be an advantage.

 

8826 - QA IT Specialist - Tipperary

Purpose:

The successful candidate will join the site QA IT team to provide independent oversight and support for the site computerised systems to ensure compliance with regulatory expectations and company Computer Systems Validation (CSV), System Development Lifecycle (SDLC), Cyber Security and Data Integrity requirements. This will include supporting day-to-day activities, such as system changes, investigations and periodic reviews, and multiple system upgrades across various business units.

Responsibilities:

  • Providing independent quality review and approval of system lifecycle documentation, such as plans, requirements, risk assessments, protocols and reports.
  • Providing independent quality review and approval of system changes.
  • Supporting and approving computerised systems investigations and deviations.
  • Ensuring consistent approach to qualification, change and deviation management across systems.
  • Providing timely and pro-active QA IT support and guidance to facilitate project timelines.
  • Where required, engaging with QA IT teams from other sites to standardise and align approach to computerised systems compliance.

 

Minimum Qualifications and Experience:

  • 5 years of experience in QA IT/CSV, CSV and/or a similar role in the pharmaceutical industry.
  • Working knowledge of relevant regulations and industry standards.
  • Proven ability to meet timelines, prioritise tasks and engage with stakeholders.
  • Excellent communication skills.
  • Project management experience will be an advantage.
  • Infrastructure, OSI PI and PAS-X experience will be an advantage

 

9049 - Process Engineer - Carlow

Purpose:

Provide process engineering services in support of the design, construction, commissioning and qualification of a Sterile Formulation and Filling Facility. The job-holder works with the company’s Process Engineering Team to act as client owner representative to deliver integrated process engineering services to meet the Project Objectives. The Process Engineer will assist in the management cross functional teams to deliver a significant suite or multiple suites of related process scope.

 

Responsibilities:

  • Support GES Process Lead to implement a Process Design based on the scope of Process Requirements provided by the Technology and Manufacturing owners.
  • Support cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables.
  • Ensure all project stakeholders are informed and consulted on key process suite activities and decisions.
  • Monitor progress of process suite team milestones with all team members and provide status reports to project Tiers and stakeholders.
  • Support the Architect & Engineering design firm to:
  • Develop Process Flow Diagrams, P&IDs, User Requirement Specifications and Equipment Specifications to ensure Process Descriptions/Needs are met.
  • Support process safety deliverables including PHA (Hazops).
  • Ensure the company and their Carlow site engineering standards, procedures and practices are followed in the design development.
  • Support GES C&Q Lead to coordinate preparation and lead FATs/C&Q field execution.
  • Develop and/or review system lifecycle documents including Criticality and Risk assessments, FAT documentation, and C&Q documentation.
  • Support installation / start-up / testing of process systems through OQ completion. Interface with cross-functional team to ensure systems’ post-OQ (PQ, PPQ) readiness.
  • Liaise with stakeholders, equipment vendors, business partners, and SMEs at other sites within the company Manufacturing Network as required to support Project.
  • On occasion, the job-holder may also undertake Project Engineering duties including:
  • Preparation of project related deliverables such as schedules, work plans, equipment cost tracking
  • Coordination of project activities between stakeholders

 

Minimum Qualifications and Experience:

  • Minimum qualification B.Sc. or M.Sc./ M.Eng Degree in Chemical or Biochemical Engineering or equivalent discipline; equivalent is defined as a Biotechnology or Industrial Chemistry Degree with basic the elements of chemical/biochemical engineering fundamentals as applied to sterile or aseptic manufacturing.
  • Minimum of 3 years post academic process engineering experience in relevant aseptic/sterile processing design, construction & start-up environment.
  • Understanding of process engineering and technologies pertinent to unit operations including Closed-Process Formulation, Depyrogenation Tunnel, E-Beam, Isolated Filling, Capping, Bioburden reduction/Sterile Filtration, and CIP/SIP is an advantage
  • The role will require periods of travel to support vendor reviews & FATs, and periodic attendance at Architect & Engineering Firm offices (Cork). Flexibility is required in this regard.

 

8147 - QA IT Specialist - Carlow

Purpose:

The successful candidate will provide QA IT oversight and support for the site computerised systems to ensure compliance with regulatory expectations and company Computer Systems Validation (CSV), System Development Lifecycle (SDLC), Cyber Security and Data Integrity requirements. This will include supporting implementation of new automated equipment and a DCS on a key site project.

 

Responsibilities:

  • Providing independent quality review and approval of system lifecycle documentation, such as plans, requirements, risk assessments, protocols and reports.
  • Providing independent quality review and approval of system changes.
  • Supporting and approving computerised systems investigations and deviations.
  • Ensuring consistent approach to qualification, change and deviation management across systems.
  • Providing timely and pro-active QA IT support and guidance to facilitate project timelines.

 

Minimum Qualifications and Experience:

  • 5 years of experience in QA IT/CSV, CSV and/or a similar role in the pharmaceutical industry.
  • Working knowledge of relevant regulations and industry standards.
  • Proven ability to meet timelines, prioritise tasks and engage with stakeholders.
  • Excellent communication skills.
  • Project management experience will be an advantage.
  • DeltaV experience will be an advantage

 

 

8550 - Automation Engineer - Carlow

Responsibilities:

  • Provide technical input into design of BMS systems
  • Generation\execution of project documentation relation to BMS systems (ACP’s, AIQ etc..)
  • Work with vendor on sFAT’s, Loop checking and SAT generation\execution
  • Be the expert for technical queries in relation to BMS systems
  • Work with site automation to ensure alignment with current systems and practices

 

Minimum Qualifications and Experience:

  • BS in Engineering, Computer Science, or other technical degree.
  • 2 or more years of experience in project/automation/IT support and/or Vaccines / Pharmaceutical Manufacturing front line supervision.
  • Excellent facilitation, problem solving, and decision-making skills.
  • Demonstrated ability to analyze and define business problems, develop business cases, and identify appropriate process and technological solutions is essential
  • Proven facilitation, meeting/workshop management, change management skills are essential, along with excellent written and oral communication skills, as well as strong presentation skills

 

9166 - HVAC Refrigeration Engineer - Carlow

Purpose:

The HVAC/Refrigeration Engineer will perform an integral role in the development of the company’s drug product facility. The Engineer will take ownership for the HVAC and refrigeration systems on site (such as, but not limited to, ISO Grade A, C and D environments; the integration of the required supporting utilities; clean steam, chilled water, heating hot water, instrument air, 2-8degC coldrooms, ambient warehousing, fumehoods, incubators, Process Chillers and local refrigeration systems). They will provide leadership, cross functional support and technical expertise to IUFT, maintenance and manage their operation through design, construction, validation, start-up and commercial manufacturing. Ensure that objectives are effectively achieved, consistent with the company’s requirements to ensure compliance, safety and reliable supply to our customers. The HVAC/Refrigeration Engineer will collaborate across functions, supporting, coaching and facilitating project sub-teams. Together, this dynamic group will meet the required project schedule milestones, in accordance with the applicable company standards for Quality and EHS compliance.

 

Responsibilities:

  • Responsible for delivery of schedule milestones throughout the project duration.
  • Collaborate and work cross functionally to develop and deliver on all aspects of the project through URS, FAT, SAT, IC, OC, IQ, OQ, PPQ and commercialization to meet schedule milestones
  • Driving operational and technical excellence to deliver all components of a stable support utility (HVAC) equipment portfolio supporting PPQ, facility start-up and commercial supply, supported by a flexible, collaborative, multi-skilled teamwork environment.
  • Assist with the design and operationalisation of a successful IUFT that delivers right-first-time HVAC/Refrigeration equipment to achieve production requirements.
  • Resolve issues and escalate risks in a timely fashion to the relevant on-site stakeholders.
  • Comply with the current company Manufacturing Division, Quality and EHS Management System requirements, as relevant to the project and commercial operations.
  • Ensure that the IUFT team receive appropriate resources and programmes to develop technical and other skills, to complete their jobs whilst stimulating personal growth and development in line with role. Develop and maintain training programmes.
  • Drive effective writing/revising/ rolling out of accurate operational procedures, training materials and maintenance procedures for various IUFT systems; ensure all work is subsequently carried out in line with same.
  • Foster a culture of continuous improvement by deploying company Six Sigma tools and support implementation of Model Area within operations from the start.
  • Expected travel – 20%

 

Minimum Qualifications and Experience:

  • General
  • Demonstrating energy and enthusiasm, the HVAC/Refrigeration Engineer, will be a role model for operational excellence, and will contribute to the organisation’s overall capability to thrive and grow.
  • Experience with GMP cleanroom facility commissioning and startup an advantage.
  • Demonstrated site operations project experience, from capital project to continuous support to manufacturing operations.
  • Proven track-record in delivering results in a world-class supply organisation.
  • A strong career history in pharma (ideally working with GMP HVAC) and familiarity with a highly regulated environment.
  • Innovative thinker, with excellent decision-making and problem-solving skills.
  • Experience of working in a cross functional environment.
  • Knowledge of and experience in applying Six Sigma and Lean methodologies.
  • Positive, flexible action-oriented attitude.
  • Technical
  • SME (subject matter expert) in HVAC/Refrigeration engineering lifecycle (design, through to sustaining operations; including ARM – asset reliability maintenance).
  • SME in HVAC and refrigeration (cleanroom environments, HVAC balancing), mechanical, electrical, fluid and pneumatic utility systems, 2-8degC coldrooms, ambient warehousing, fumehoods, incubators, Process Chillers and local refrigeration systems.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
  • Report, standards, policy writing skills required
  • Proficiency in Microsoft Office and job related computer applications required
  • Lean Six Sigma Methodology experience desired
  • Lead, promote, participate and supervise the implementation and maintenance of the relevant safety programmes.
  • Delivery of safety, performance and quality goals.
  • People
  • Ability to participate in and lead highly-effective teams.
  • The desire to continuously learn, improve and develop.
  • A great communicator, decisive decision-maker with a proven ability to deliver excellence
  • Strong leadership and interpersonal skills.
  • Willingness to support the team and a strong focus on delivering excellence.
  • A passion for coaching others by sharing your skill-set and expertise.
  • High personal integrity, credibility, energy and flexibility.
  • Model the company leadership behaviours and use the MPS principles to achieve project success.
  • Build diverse talent with the capabilities necessary to succeed in commercial vaccine manufacture; inspire, reward and develop to ensure individuals reach their potential; make tough calls when necessary.
  • Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results.
  • Education
  • Degree qualification or equivalent (Science, Engineering, Technical).
  • Experience in manufacturing in a GMP HVAC environment utilizing ISO 14644-1 classifications (such as Grade A, C and D.)
  • Evidence of continuous professional development is desirable.

 

2019-236 - Senior Regulatory Affairs Specialist - Waterford City

Responsibilities:

  • Support all aspects of the EU Authorised Representative function in Ireland for the company.
  • Deputise for the Regulatory Affairs Manager for all regulatory body communications.
  • Provide EU Regulatory subject matter support to the Vision Care business for key projects and activities.
  • Serve as the person responsible for regulatory compliance for the EU Authorised Representative.
  • Develop and maintain a good knowledge of the Vision Care product portfolio.
  • Verify the EU Declaration of Conformity, Technical Documentation and Conformity Assessment carried out by the legal manufacturer.
  • Maintain the Authorised Representative registration with the Irish competent authority (HPRA) and maintain product registrations for Vision Care products.
  • Submit Field Safety Corrective Action (FSCA) Reports and Field Safety Notices (FSN) in the EEA, Switzerland and candidate countries on behalf of the legal manufacturer.
  • Field questions from competent authorities regarding product performance and/or vigilance and recall on the EU market.
  • Work with the legal manufacturer to provide responses to questions from competent authorities.
  • Participate in notified body and competent authority inspections of Vison Care legal manufacturer and manufacturing sites.
  • Manage the process for provision of certificates of free sale for Vison Care to support maintenance of business and/or market expansion including authentication, apostille and embassy legalization.
  • Upgrade the Authorised Representative policies, procedures and work instructions for EU MDR compliance.
  • Provide advice regarding interpretation of MDD 93/42/EEC and MDR 2017/745 including associated guidance (e.g. Meddev, Common Specifications etc.).
  • Support key EU MDR work streams (e.g. economic operators, technical files, quality systems).
  • Contribute to discussions internally and with notified body and competent authorities.
  • Willingness to travel on company business 10-15% of time.

 

Minimum Qualifications and Experience:

  • Minimum bachelor’s Degree BS in an engineering or scientific discipline or a Master’s degree MS in regulatory affairs or a related discipline.
  • 4-5 years’ experience in regulatory affairs.

 

9376509 - Technical Specialist - Dublin

Purpose:

The Purification (Downstream) Technical Specialist has primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS) as part of the Technical Services Team at the company’s facility in Dublin. The Technical Specialist will provide protein purification processing expertise to support the facility design, start-up and routine commercial manufacturing for chromatography, UFDF/TFF filtration, Viral filtration technologies and bulk fill unit operations respectively.

The Technical Specialist will be responsible for providing support for technology transfer of new/existing drug substance (DS) manufacturing processes to the Dublin facility, and will be required to work in close collaboration with Process Development, DS Process Sending unit, Operations, Engineering, Supply Chain, Quality, Quality Control, Regulatory and other involved departments to ensure successful facility start-up and process qualification (PPQ). The position is accountable for timely completion of technical transfer related milestones, with particular emphasis on new product introduction, Process Owner for purification unit operations, Process Validation (PPQ), Process Monitoring, Risk Assessment (using QRM tools), and building strategies / SME capability.

 

Responsibilities:

  • To provide process expertise in the area of buffer preparation, large scale protein purification drug substance manufacturing process (column chromatography, VI, UFDF/TFF, Viral filtration and bulk fill) to support the successful startup of the company’s BDS facility in Dublin.
  • Working knowledge of typical chromatography and filtration unit operations and functional purpose, cause and effect, in-process tests, and mass balance principles.
  • To author and review process transfer documentation, gap assessments, technical protocols and reports, including process validation documentation & strategy documents.
  • To identify requirements for laboratory studies to support process fit, decisions or process transfer, and to liaise closely with Global Process Development to input to the design/ execution of studies.
  • To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications and outline testing requirements.
  • To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines.
  • To identify and implement process and continual improvements; e.g. yield, cycle time reduction etc.
  • To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale.
  • May be required to work periodically out of normal business hours (temporary shift working) during periods of engineering and validation batch execution as required, and participation in on-call roster.
  • To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution with CAPAs.
  • Lead any key process changes using change control management system.
  • Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits.
  • Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits and incident investigations.
  • To author and review IND, BLA and other technical documents for regulatory agency submissions.
  • To serve as a subject-matter expert (SME) on technology transfer and process unit operations support during regulatory agency inspections.

 

Minimum Qualifications and Experience:

  • Minimum requirement would be B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or Eng. Process or Chemical Engineering. A higher degree (M.Sc. or Ph.D.) would be an advantage
  • Minimum 5 years’ experience in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organization.
  • Technical and operational knowledge of multiple unit operations in downstream protein purification processing (chromatography, filtration, TFF).
  • In-depth technical and operational knowledge of multiple unit operations in downstream processing, including buffer preparation, industrial scale protein purification, TFF filtration, final fill, nano and process filtration.
  • Strong understanding of technology transfer, scale-up process and cleaning validation.
  • Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliant.
  • Experience of Validation / Verification of GMP equipment or processes would be beneficial.
  • Experience of design, commissioning and start-up of a bulk drug substance facility would be beneficial.
  • Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization, and in local group settings.
  • Ability to present and defend technical and scientific approaches in both written and verbal form.
  • Ability to drive for results independently and adapt to rapidly changing priorities
  • Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
  • Technical writing competency.
  • Experience of authoring CMC sections to support regulatory submissions would be advantageous.
  • Experience of Technology Transfer activities is advantageous.
  • Experience of disposable technology would be advantageous.
  • Knowledge or experience of start-up or systems would be ideal.

 

2019-254 - Project Engineer - Dublin

Purpose:

A vacancy exists for a P5 Project Engineer within the Technical Services Department. Reporting to Engineer Project Manager. You will be working within cross-functional teams with a high-level of autonomy; playing a key role in Schedule Preparation, Pre-Planning and Resource Forecasting along with Project Management of Opex and Capex Projects on site.

Responsibilities:

  • To lead projects taking the role of Engineering Team Leader, from project registration right through to validation/commissioning and hand over, as per Engineering SOP for ‘Project Management’ ensuring that projects are completed to specification, within budget and on programme.
  • To liaise with the project requester and define exactly the project brief.
  • To liaise with customer department as well as other Business Unit departments and support departments as required such as EHS, Tech Services, and Logistics etc.
  • To attend regular planning meetings as required to ensure plant downtime is agreed.
  • To make justifiable decisions at all times which will not compromise quality, capacity, flexibility, operability, security or EHS compliance.
  • To immediately report to the Engineer Project Manager any deviations from the project plan which would have an impact on quality, specification, programme or cost .
  • To ensure that adequate training is provided to Production and Engineering personnel, and to assist in any way that is practical.
  • Chairing of design review meetings, site meetings, haz-ops, project meetings etc.
  • To ensure that Project are handled and managed using the ’team’ approach.
  • Ensuring that the Engineer in particular and the Department as a team are kept up to date in current engineering technology and work practices by attending, with approval, relevant seminars, exhibitions, training/educational courses and by reading engineering literature.
  • To follow up snags ensuring that the project is completed fully, before closing the Capital Account.
  • To communicate effectively within the Department Function and particularly with the customer.
  • Ensure that all procedures described in the Department SOP’s or WI’s and Guidelines are strictly adhered to.
  • To ensure that plant hand over, including the preparation of documentation packages is carried out in a controlled and punctual manner as per company procedures.
  • To plan, manage, co-ordinate and design the ’front-end’ design of the project whilst evaluating quality and value relative to practicalities.
  • Preparation of equipment specifications, budget estimates, scope documents, IA submittals, purchase requisitions, cost control data sheets, meeting minutes and circulation of same.
  • To prepare installation specifications as per Standard Procedures and to complete AWP’s for all work.
  • To oversee and control CAD services to ensure drawings are registered, prepared, checked, approved, circulated and controlled as per SOP for ’Registration and Control of Engineering Drawings’.
  • To act as safety lead in line with construction regulations 2013 and appoint PSDP and / or PSCS as required. Also, to ensure EHS risk assessment carried out and actioned prior to capital submittal.
  • To liaise with appointed external consultancy practices as directed, ensuring that the consultant operates to company procedures within a team framework.
  • To source, select, procure, inspect, approve and oversee installation of equipment, machines and systems.
  • To ensure that current regulations, standards and work practices are adhered to for all project work, i.e. FDA, HSA, HPRA, EPA, British Standards, USP, ETCI etc.
  • For engineers managing direct impact projects they must carry out the commissioning and qualification phases as per SOP_002492.
  • To liaise with Q.A Compliance ensuring that regulatory and validation issues have been addressed in an approved manner.
  • To follow up on qualification deviations.
  • To manage and control contractors working on company site, ensuring that work practices comply with the relevant sections of the 2013 Construction regulations, company Standards and cGMP.
  • To ensure decisions, work practices or use of certain contractors do not expose the company to the risk of an industrial dispute.
  • To ensure that training records are adequate and kept up to date.
  • Ensure that change control procedures are strictly adhered to.

Additional Duties:

  • Sterile Processing – Bulk and Filling Operations
  • Good understanding of sterility requirements/environmental monitoring requirements
  • Grade A/B environment/exposure
  • Good understanding of aseptic techniques and technology
  • Cleaning Validation CIP/SIP (Stem in place)
  • Media batch experience/incubation
  • Understandings of Autoclave technology
  • Strong documentation skills
  • Good Understanding of Regulatory requirements
  • Audit Experience.

 

Minimum Qualifications and Experience:

  • 3rd Level Qualification in an Engineering discipline
  • For Engineers working on ‘Direct-Impact’ projects, they should have minimum 3 years pharma experience, and 5 years total experience.
  • For Engineers working on ‘Indirect – Impact’ projects, they should have minimum 5 years’ experience.

 

2019-257 - Senior Project Engineer - Dublin

Purpose:

A vacancy exists for a P4 Senior Project Engineer within the Technical Services Department in our client’s Dublin facility. You will be working on one main high priority CapEx project within cross- functional teams with a high- level of autonomy; playing a key role in Schedule Preparation, Pre- Planning and Resource Forecasting along with Project Management of Opex.

Responsibilities:

  • To lead the project taking the key role of Engineering Team Leader, from project registration right through to validation/commissioning and hand over, as per Engineering SOP for ‘Project Management’ ensuring that projects are completed to specification, within budget and on programme.
  • Manage and co-ordinate the necessary resources to ensure effective execution of the design, costing, programming, installation and validation phases of all major capital projects.
  • Following a project installation phase, implement the Plant hand back procedures by paying attention to engineering commissioning, check-lists and follow-up. Provide an Engineering C&Q function to the company.
  • Manage and co-ordinate the necessary resources to ensure effective execution of the design, costing, programming, installation and validation phases of this major capital project.
  • Monitor contractors to ensure the company gets value for money and contractors are of the highest quality.
  • Initiation and preparation of project related plans, schedules, reports, feasibility studies, analysis, budget parameters. Prepare and maintain a regular project reporting format. Provide business cases, justifications and strategy input to major projects.
  • Ensure that the Project Department liaise effectively with all areas within Technical Services.
  • Motivation of staff to ensure procedures and design is of the highest standard.
  • Pay due care and attention to Health and Safety and Environmental issues.
  • Ensure that all companywide procedures are adhered to within the Department and Ensure that all documentation is following the Engineering Department Standards.
  • Liaise with the Department customers ensuring that their requirements are fully understood and that their expectations are met.
  • Ensure that all staff and contractors receive adequate training in relevant areas and that training is reviewed on an annual basis.
  • Ensure that all work carried out is to the highest standard and is in accordance with international and regulatory standards.
  • To manage and organise effectively with CapEx Manager the Project Managers required for the project from Technical Services Department.
  • Deliver the Project within budget and on time.
  • To provide strong leadership and coaching to all departmental personnel so that they actively support activities that improve performance.
  • To lead the Project with a proactive approach.

Minimum Qualifications and Experience:

  • Minimum 10 years’ experience in the Pharma industry, preferably in a management / supervisory role
  • Must have 3rd level Engineering qualification or equivalent Project Management/ Financial – Business qualification

 

2019-256 - Production Specialist - Dublin

Purpose:

A vacancy exists for a Production Specialist within the Production Support Department. Reporting to the Production Support Manager, your role will be part of a team responsible for a variety of key area’s within the production departments. You will be required to have a strong understanding of the compliance standards required in a pharmaceutical production environment. You will be working within cross-functional teams with a high-level of autonomy; playing a lead role in process investigations, identifying root cases and delivering process improvements.

Responsibilities:

  • Carrying out thorough and structured investigations into process issues
  • Proactively working on process improvements before issues occur
  • Leading and implementing change to key areas of production
  • Supporting the on time release of product as required
  • Act as the SME for production processes in cross functional teams/projects

Minimum Qualifications and Experience:

  • Third level qualification (NFQ Level 8 or higher) in Process Engineering or a relevant discipline
  • Minimum of 5 years relevant experience within the Pharmaceutical industry
  • Broad ranging process improvement based experience & problem solving abilities
  • Knowledge of bulk production, filling and packaging processes and techniques
  • Strong understanding of GMP and a right first time approach
  • Competency and experience in structured problem solving. Lean six sigma certified to a Green belt level or higher
  • A “ can do” attitude and genuine enthusiasm for driving improvements
  • A positive mindset of Safety First
  • A confident team player who can work with a high degree of autonomy.
  • Ability to engage and influence key internal stakeholders so that they can deliver on improved performance

 

9367691 - Warehouse Associate - Dublin

Responsibilities:

  • Ensure all training on equipment, processes, and facility and safety procedures are maintained and up to date at all times
  • Perform day-to-day warehouse activities to meet schedules while maintaining a high level of GMP compliance
  • Maintaining the Warehouse Quality System by adherence to all relevant SOP’s, policies and cGMP requirements
  • To aid with troubleshooting and resolving operational problems
  • Act as a subject matter expert for the Warehouse group in relevant equipment and system root cause investigations and fill the role of lead investigator where required
  • Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved
  • Report to Warehouse Supervisor on a regular basis on area performance and report any issues that need to be resolved
  • Proactively ensuring that all Environmental, Health and Safety responsibilities are carried out according to EHS regulations and procedures
  • Maintaining spare parts, change parts etc. in the Engineering Stores
  • Utilising and maintaining IT systems as required, e.g. SAP
  • Provide support to Operations, Validation, Engineering and Quality where required
  • Complete training with new/junior Warehouse Operators
  • Other duties as required

Minimum Qualifications and Experience:

  • Current or previous formal education in logistics/warehousing/supply chain would be an advantage
  • 2-5 years’ experience performing Warehouse support activities preferably in a cGMP commercial manufacturing environment
  • Must be able to work within and adapt to complex electronic systems such as SAP
  • Good interpersonal, communication and problem solving skills
  • Should be knowledgeable of regulatory and GMP requirements

 

2019-250 - Analyst - Shift - Shanbally

Purpose:

The primary purpose of these roles is to provide support to internal and external customers by providing quality testing, delivering results in accordance with GMP standards and ensuring products are safe for patient use and fit for purpose.

Responsibilities:

  • Perform TOC/Conductivity, Wet Chemistry and other Chemistry testing
  • Microbiological testing including Bioburden and Endotoxin testing
  • Perform primary review of QC raw data and trend results
  • Draft QC SOPs
  • Evaluate results against defined acceptance criteria
  • Conduct and document laboratory investigations to completion

Minimum Qualifications and Experience:

  • A degree in Microbiology, Chemistry or a related discipline is required with a minimum of 1 year within a pharmaceutical regulatory environment
  • Ability to work independently and meeting established timelines.
  • Knowledge of cGMPs
  • Excellent communication skills both written and verbal
  • Customer focus; takes personal responsibility for speed; quality and accuracy of delivery
  • Self-motivated and ability to work under pressure
  • Successful track record in achieving goals as part of a team within a growing, dynamic environment
  • Demonstrated adaptability and flexibility to support a growing organisation.
  • Please note that these roles will involve continental 12 hour shift work and a shift premium will be provided for this.

 

2019-249 - Biochemistry Analyst - Kinsale

Purpose:

This position is to support the Biochemistry team and will require analytical skills to troubleshoot laboratory issues. The position will involve CIEF testing, HPLC, CSDS testing and possibly Chemistry testing.

The Ideal Candidate Would Have:

  • Strong scientific and organisational skills
  • Excellent communication, both oral and written
  • Excellent attention to detail
  • Ability to work independently and as part of a team, with self-motivation, adaptability, and a positive attitude
  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
  • Good working knowledge of cGMP
  • Authorisation to live and work in the Republic of Ireland indefinitely without restriction or sponsorship

 

Minimum Qualifications and Experience:

  • A 3rd level qualification in a scientific discipline
  • At least 1 years’ analytical laboratory experience in a GMP environment
  • A good knowledge of HPLC, Empower, Stability, SDS-Page, IEF, CE, plus general laboratory skills (balance, pipette, cleaning, equipment management etc.) is required
  • Experience with LIMS systems is desirable

 

2019-247 - Microbiology Analyst - Kinsale

The Ideal Candidate Would Have:

  • Microbiology In-Process and Final Product Testing (Bioburden/Endotoxin in particular)
  • Environmental Monitoring
  • Method Transfer/Validation (Bioburden/Endotoxin)
  • Water Utilities Testing
  • Method Updates/Report Writing (Micro)
  • Knowledge of LIMS and Trackwise would be a distinct advantage

 

Minimum Qualifications and Experience:

  • A degree in microbiology or a related subject
  • At least 18 months’ experience in a microbiology laboratory
  • At least 1 years’ experience in a GMP environment
  • Good team player, organised, accurate, have strong documentation skills
  • Flexible, adaptable to changing priorities
  • Passionate about quality and client service
  • Good communication skills both internally and externally
  • A flexible approach to changeable working patterns and be available for shift work should it be required

 

2019-245 - Release and Stability Chemist (R&D) - Waterford City

Purpose:

To analyse stability products to agreed schedules and in accordance with regulatory requirements. To assist other R&D groups in the testing of In Process and Finished Product samples if required.

Responsibilities:

  • To test submission stability products in a timely and efficient manner to agreed schedules and in accordance with Regulatory requirements.
  • To assist other R&D groups in the testing of In Process and Finished Products if required.
  • To review test methods and draft stability protocols as applicable.
  • To prepare submission documentation in support of license applications.
  • To take part in any laboratory investigations/troubleshooting.
  • To trend analytical data as required.
  • To liase directly with customers and contract laboratories and attend conference calls as required.
  • To attend internal project review meetings as required.
  • To assist in the preparation for customer/ regulatory inspections.
  • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  • To ensure that all work is carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • To complete all documentation correctly, in line with data integrity guidelines, free from errors, omissions or defects in order to achieve a high level of customer service and cGMP. To peer review documentation as required.
  • To perform additional team tasks as agreed to support effective running of the Business.
  • To support all other on-going laboratory functions & requirements.
  • Health & Safety
  • To ensure the requirements of the company’s Safety Statement are implemented.
  • To continuously promote a positive safety culture by leading by example.
  • To implement safety requirements as per site documentation including SOP’s, Safety Statement and COP’s.
  • To report any defects/hazards

 

Minimum Qualifications and Experience:

  • Qualified to a minimum of degree level in chemistry, pharmaceutical science or a related discipline.
  • At least two years experience working in a related technical environment.

 

2019-229 - QA Group Lead - Clonmel

Purpose:

Provides supervision and leadership to the team of Quality Engineers, Technicians and auditors as required, to support Manufacturing, Supplier Development, New Product Development and Quality Systems. Ensures the overall compliance and effectiveness of the quality system with established requirements and quality system regulations. Directs projects to ensure the manufacture of high quality product and to facilitate compliance with requirements. Evaluates performance of direct reports and supports career development activities. Ensures that program and project objectives are met, budgets are adhered to and metrics are captured and published.

Responsibilities:

  • Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes and coordinates the selection process with Human Resources.
  • Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
  • Monitors daily work operations and provides direction and guidance to experienced exempt employees, or skilled non-exempt staff to achieve unit or project goals.
  • Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.
  • Interprets and executes policies that affect work processes and personnel within the assigned organisational unit.
  • Contributes to the development of operational policies and procedures that affect personnel within the assigned organisational unit. Monitors compliance with company policies and procedures (for example, compliance with Food and Drug Administration (FDA), British Standards Institution (BSI) and relevant employment law.
  • Monitors internal and external indicators by reviewing reports and newsletters, reading organisation literature, meeting with peers and reading departmental reports.
  • Contributes to the development and monitoring of area budgets through regular analysis of cost
  • Translates department goals into individual objectives and goals.
  • Identifies, develops and implements process and opportunities to enhance and improve overall department performance.
  • Provides manufacturing support by defining work assignments directed to address manufacturing process defects and implement process improvements utilising quality system tools.
  • May also direct work assignments for quality control auditors.
  • Directs quality personnel to support new product development by defining projects focused on new products/process development based on coordination with management, project leaders and design engineers.
  • Implements improvements to quality system and tools by directing personnel to gather data on existing quality tools, identifying weaknesses and research/select new tools based on findings and implementation of revised systems.
  • Ensure sustaining support of quality system and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.
  • Participates in validation activity.
  • Role may vary between providing input to owning activities such as protocol/report writing and managing execution of validation activities.
  • Maintains personnel records and where appropriate develops work schedules for department personnel.
  • Responsible for disposition and investigation of any identified nonconforming materials or product identified via incoming inspection or production.
  • Responsible for management of supplier, internal and external audits, planned and unplanned, ensuring all audits are conducted as per plan audits are closed out in a timely fashion as per governing procedures.

 

Minimum Qualifications and Experience:

  • Experience/Education
  • National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline and 6+ years of related work experience or an equivalent combination of education and work experience
  • Technical/Business Knowledge
  • Monitors progress of exempt individuals, teams, supervisors or non-exempt technical individuals toward departmental goals. Monitors costs of projects and of human and material resources within a department or unit. Monitors external environment in area of technical or professional responsibility. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations
  • Cognitive Skills
  • Develops and/or identifies new work processes and the improved utilisation of human and material resources within the assigned area or related departments. Facilitates others involvement in the continuous improvement program. Investigates and solves problems that impact work processes and personnel within the assigned unit.
  • Influence/Leadership
  • Promotes the attainment of group goals by selecting , motivating and training ca able staff. Provides guidance towards achieving group objectives.
  • Planning/Organisation
  • Schedules human and material resources within a group or selection in conjunction with near term plans to ensure their availability. Carries out operations within an established budget.
  • Decision Making/Impact
  • Assignments are expresses in the form of tasks and objectives. Generally makes day-to-day decisions within established guidelines regarding work processes or schedules in order to achieve the program objectives established by senior management. Consequences of erroneous decisions would normally result in serious delays to assigned projects or operations with substantial expenditure of time, human resources and funds, without jeopardising future business activity, (Supervision Received) Works under minimal supervision. Independently determine and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.
  • Supervision Provided
  • Provides direction and guidance to supervisors, experienced exempt and/or skilled non-exempt levels of employees. Evaluates performance of and assists in career development planning for subordinates. Often responsible for a local functional or process activity.

 

2019-235 - Senior Financial Reporting Manager - Waterford City

Description:

As Senior Financial Reporting Manager, the person will be responsible for key financial processes within the organisation. The person will be responsible for a number of legal entities with the emphasis on ensuring that all statutory and tax reporting requirements are achieved, and that systems and processes are maintained and enhanced to ensure reporting requirements, both local and internationally, can be delivered in an efficient manner. In addition, the person will have responsibility within the monthly close process, ensuring timely and accurate submissions to Head office and ensuring key SOX controls are maintained. As a senior member of staff, the person will also liaise with Corporate Head office, presenting and explaining results. To this end the individual will need to gain very quickly an understanding of the business and how it operates and build key relationships within the Corporate organisation. The person appointed will need to have initiative and drive to work in a fast paced, ever changing environment. Excellent communication skills and an ability to work well within a small team are essential.

Responsibilities:

  • Full responsibility for all legal entity reporting:
  • Annual Statutory financial statements
  • Interim Statutory financial Statements
  • Annual Statutory Audit
  • Creating processes to ensure financial statements can be delivered efficiently
  • Interpreting legal documentation and accounting appropriately
  • All CSO and other statutory reporting requirements
  • SOX compliance for relevant areas
  • Tax Compliance Reporting for all legal entities:
  • Tax provisioning – current & deferred tax
  • Annual tax submissions and queries
  • Tax reporting to Corporate Tax Group
  • Tax planning with Corporate Tax Group
  • Other key responsibilities:
  • Management Fee accounting & reporting
  • FX analysis for legal entity
  • Preparation of presentations for board meetings
  • Responsibility for Government support initiatives
  • Managing grant agreements from inception to close
  • Grant applications
  • Grant claims
  • R&D Tax credits

 

Minimum Qualifications and Experience:

  • Qualified Accountant with 8+ years post qualification experience
  • Experience in accounting for complicated financial structures
  • Good working knowledge of accounting software packages required – Peoplesoft, SAP, HFM
  • Advanced Excel skills

 

2019-259 - Validation Engineer - Wicklow

Description:

As part of the Validation team within Quality, the Validation Engineer will be responsible for the performance and execution of Production and Cleaning Validation. The primary focus of the role will be on validation transfers of existing products to new equipment within the site.

Responsibilities:

  • Responsibility for the co-ordination of Process Validation, Cleaning Validation activity and Equipment Validation in the Production Department.
  • Preparation and execution of validation and re-validation protocols and reports, (IQ / OQ / PQ), for the validation of equipment, systems, products and projects.
  • Responsible for Investigating and resolving deviations associated with validation studies.
  • Acting as the primary point of contact for all Production related Validation matters as well as internal and external compliance audits or regulatory inspections.
  • Process Validation regulatory requests relating to the VMP.
  • Contribute to achievement of VMP and site targets.

Minimum Qualifications and Experience:

  • The successful candidate will be expected to work co-operatively and flexibly both within the Quality and Production department and with other departments across the site.
  • Excellent communication skills with a collaborative approach to work are also required.
  • Strong attention to detail, refined planning and organisation skills along with an ability to achieve objectives without close supervision in a team based environment are essential for this role.
  • A minimum of two years’ validation experience within the Pharmaceutical/Medical Devices Industry is required. Candidates should hold a Degree level qualification in a scientific or relevant discipline.

 

2019-244 - Senior Microbiologist - Waterford City

Description:

To be part of a microbiology department supporting state of the art Fill Finish and Oral Solid Dose facilities.

Responsibilities:

  • Laboratory
  • Introduction, validation and execution of methods.
  • Review and trend data.
  • Write, execute and approve validation documents as required.
  • Carry out investigations and address deviations.
  • Management of external testing.
  • Write, implement, review and update SOPs.
  • Support junior staff

 

  • Health, Safety and the Environment
  • Comply with all EHS policies and procedures.

 

  • Quality Compliance
  • Comply with all GMP, GLP and GDP requirements.

 

  • Production
  • Provide technical knowledge and support on sterility assurance.
  • Provide support during Media Fills.
  • Participate in risk assessments as a Subject Matter Expert (SME).
  • Provide support during production investigations.

 

  • Delegation
  • Provide support to the microbiology manager.

Minimum Qualifications and Experience:

  • BSC in microbiology or biological sciences.
  • Minimum of 5 years of experience in microbiology in a laboratory and / or aseptic production environment.
  • Demonstrated experience in providing microbiological support to a production facility.
  • Demonstrated ability to introduce, validate and optimise microbiology methods.
  • Experience working in a cross functional team environment.

 

  • Skills:
  • Introduction, validation and performance of sterility testing.
  • Operation of sterility testing isolators.
  • Microbial Limit Test validation.
  • Media Fill experience.

 

2019-260 - QC Specialist for LIMS - Meath

Description:

This role will support the Quality Control functional testing of incoming raw materials, in-process drug substance/drug product, final drug products, stability samples and environmental monitoring of the controlled manufacturing areas and utilities at the new single-use multi-product biotech facility. This facility will manufacture enzyme replacement and antibody-based therapies for a leading global biotech company focused on rare diseases. The overall responsibility for this role will be to support the Quality Control testing function, ensuring compliance with cGMP and corporate regulations. This is a critical role within the Quality organisation to help establish the Laboratories as a hub for specialised analytical testing and create value for our patients.

Responsibilities:

This role is associated with the data management systems for instrument control in the laboratories, this includes but is not limited to Labware LES (LIMS + Execution System), Lonza MoDa, Waters Empower, Mettler Lab-X. Below activities are associated with these systems;

  • Participates in defining user requirements.
  • Tests and validates the design.
  • Develops procedures and training documents.
  • Assist in the implementation at site.
  • Gather raw data for template building.
  • After vendor provided training will provide the first line of support within their laboratories.
  • Empower superuser to build and maintain custom calculation builds and system maintenance.
  • Reviewing analytical data, analytical reports and performing peer reviews.
  • Instrument qualification, maintenance and troubleshooting.
  • Protocol generation– method verification/transfer.
  • Providing training for team members.
  • Following all relevant Standard Operating Procedures.
  • Ensuring strict adherence to site policies, GMP and environmental, health and safety regulations.
  • Complies with all pertinent regulatory agency requirements.
  • Execution and on-time completion of required training activities.
  • Conducts thorough data review to ensure completeness and accuracy of records.
  • Reviews test results to ensure compliance with standards; reports any quality anomalies.
  • Participates in Laboratory Investigations as required.
  • Writes and revises control test procedures and SOPs as required.
  • May interact with outside customers or functional peer groups.
  • Promotes and exhibits company Values.
  • Executing company policies.
  • Ensuring self -inspections are performed.
  • Ensures new/revised quality system requirements are deployed to the Site

Minimum Qualifications and Experience:

  • A Level 8 Bachelor’s degree in a technical discipline (e.g. biochemistry, chemistry, engineering etc).
  • Previous GMP laboratory experience in the biotechnology and/or pharmaceutical industry.
  • Excellent communication skills (written and oral).
  • An understanding of cGMP requirements for manufacturing and/or systems and compliance.
  • Required to work on his/her own initiative in addition to working as part of a team.
  • Excellent time management & organisational skills.
  • An understanding in analytical methodology (e.g. HPLC, ELISA, SDS-Page, Glyco analytic, Bio- Assays, PCR, capillary electrophoresis, compendial assays).
  • A working understanding of GMP, ICH, USP and global compendia regulations and guidance’s, particularly as related to analytical method development and validation.
  • Previous experience with laboratory management systems such as LIMS/ MoDa/ Lab-X and / or Empower systems and interest in coding/ script.

Key Skills & Competencies:

  • Excellent trouble-shooting and problem-solving skills.
  • Ability to challenge the status quo with a continuous improvement mindset.
  • Promoting a culture where diversity and inclusion is part of the DNA.

Complexity & Problem Solving:

  • Identifying and communicating risks in area of responsibility and across the site.
  • Creating strategies and plans to manage risk within the Quality Control operation.

Internal and External Contacts:

  • For product quality, collaborates with Manufacturing, Science & Technology (MS&T) and Manufacturing Operations but is responsible for providing information to support the QMR decision.
  • For quality and compliance, collaborates with the QMR but accountable for creating a ‘right first time’ culture in the Quality group to support quality excellence.
  • For safety, the individual is accountable to drive a culture of ‘everyone owns safety’ with input from the EHS lead.
  • For continuous improvement collaborates with Business Excellence peers across the Biologics business unit in the company and through external forums to drive business excellence in Quality Assurance.

2019-234 - Engineer - Process and Equipment - Waterford City

Description:

This position is to support manufacturing systems. Technical expertise is required to maintain, develop, debug and troubleshoot process & equipment issues.

Responsibilities:

  • Develop and implement process and equipment improvements with minimal impact to production operating under 24/7 environment.
  • Identify and eliminate repetitious machine failures.
  • Provide support to the Manufacturing, Maintenance, and Equipment Design groups.
  • Utilise Lean Six Sigma tools along with data to drive continuous improvement. Objective to minimise scrap, increase yield, reduce turn-around-time, minimise manufacturing downtime and costs and ensuring quality manufacturing within given specifications
  • Developing a detailed understanding of the process and automation systems in the manufacturing process, and sharing of technical expertise with colleagues.
  • Develop methods to ensure personnel engaged in maintenance activities have sufficient knowledge to perform their assigned tasks.
  • Generate documentation and SOPs associated with each of the equipment or process systems as required
  • Present, where appropriate, technical data to internal/external audit and inspection groups.
  • Ensure highest level of Health and Safety is considered and adhered to at all times for self and others
  • Equipment installation and validations
  • Process \ Equipment Engineers may lead projects \ project teams

Minimum Qualifications and Experience:

  • Bachelors in Engineering (mechanical\electronic) preferred.
  • A minimum of 4 years in technical role in high volume manufacturing environment preferred.
  • Good problem solving abilities – able to identify facts, consider alternative approaches and evaluate the most appropriate action.
  • Six sigma experience preferred.
  • Medical device and/or pharmaceutical industry experience preferred
  • Experience working in a validated environment with strong discipline with regard to change control is preferred.
  • Ability to share technical expertise with colleagues, must be able to express information clearly and concisely both verbally and in writing

 

2019-232 - Engineering Project Manager - Waterford City

Description:

Engineering Project Manager is responsible for the leadership of engineers and Project Management for new medical device manufacturing systems, products and cost improvements.

Responsibilities:

  • Use skills of analysis to identify, quantify and justify improvement opportunities.
  • Develop URS documentation for equipment and machine controls software systems.
  • Develop and implement new technologies and systems to support R&D projects.
  • Create and manage project schedules and budgets.
  • Communicate project information to all stakeholders (across many sites).
  • Identify, manage and mitigate project risk.
  • Identify and resolve project issues.
  • Demonstrate leadership skills to engage team members.
  • Demonstrate team building skills with motivated team members working well together.
  • Job will require travel to the USA and central Europe as project mix dictates.

Minimum Qualifications and Experience:

  • Bachelor level degree in Engineering or other relevant technical equivalent. Master qualification advantageous
  • 10+ years’ experience of project execution and supervision of engineers
  • Experience with medical device and/or pharmaceutical production required (cGMP / FDA regulated environment)
  • Knowledge of some of the following; software development life-cycle, GAMP V, SPC, DOE, Statistical Analysis, and Project Management (PMI certification a plus)
  • Project Management of high volume, low-cost manufacturing systems (may include pneumatics, PLCs, motion control, robotics, HMIs and SCADA)
  • Capable to lead, motivate and access engineers and others in project execution and technical development work streams
  • Self-directed. Excellent communication skills. Ability to form relationships with stakeholders from many sites and work within cross functional teams

 

Senior Project Coordinator (Project Manager R&D) - Clonmel

Responsibilities:

  • Responsible for compliance with applicable corporate and divisional policies and procedures. Estimates project levels of effort and resource requirements by using standard estimating techniques and tools, and by working with appropriate staff to understand scope of effort.
  • Prepares project plans, schedules and budgets by using project management tools such as Microsoft Project and by working with appropriate staff to understand tasks necessary to complete project.
  • Directs project execution by assigning tasks, tracking project schedules, identifying risks, and developing and executing contingency plans.
  • Assures project quality by using standard development methodologies and by working with the Supplier Quality Associate (SQA) to develop and execute project quality plans. Communicates project status by preparing standard status reports, and by participating in departmental and customer project status update meetings.
  • Resolves project issues by working with team members, project customers, and others as appropriate.
  • Participates in external project management organisations, conferences and seminars to keep current with industry best practices in project management by joining professional associations and implementing a professional development plan with focus on project management.

Minimum Qualifications and Experience:

  • National Framework of Qualifications level 7 qualifications in a relevant discipline.
  • 4+ years of related work experience or an equivalent combination of education and experience

 

9060112 - Laboratory Investigation Specialist - Dublin

Description:

This position is responsible for conducting and documenting investigations associated with the company’s Quality Control Laboratory – Laboratory Investigation Reports (LIRs) and deviations In this role, you should have excellent investigational, root cause analysis and problem-solving skills. Relationship building, a high attention to detail and excellent verbal and written communications skills are vital to success in the role.

Responsibilities:

  • Conduct and document investigations associated with the company’s Quality Control Laboratory in a complaint and timely manner
  • Conduct root cause analysis
  • Develop and document Corrective and Preventative Actions (CAPAs) and associated CAPA
  • Effectiveness Checks (EC)
  • Track and trend investigations and associated root cause types
  • Provide training and mentoring for Laboratory Staff
  • Identify process improvements within the function and drive the initiative forward to implementation and effectivity
  • Comply with internal SOP’s, standards and associated training
  • Support the Quality Control, with responsibility to develop processes
  • Responsible for assigned LIR, CAPA’s, Change Controls & Deviations program and initiate
  • Corrective Action plans in the company’s Quality Management System, TrackWise
  • Maintain regular and proactive communication with all stakeholders

Minimum Qualifications and Experience:

  • At least 5 years’ working in Pharmaceutical quality operations
  • Degree in science/pharmaceutical related subject
  • Knowledge and understanding of GMP standards
  • Strong problem solving experience
  • Familiar with continuous improvement initiatives
  • High level of experience of conducting Laboratory Investigations, root cause analysis and CAPA development
  • Highly Computer literate, with MS Office (Word, Excel)
  • Experience of provision training to others
  • Experience of working in a GMP Quality Control Laboratory or Quality Assurance Unit

Senior Quality Engineer - Clonmel

Description:

Provide process & quality engineering support to manufacturing, helping to ensure delivery of the highest quality product to customer. Provide process & quality engineering support to product development teams, helping to ensure development of the highest quality of new products.

Responsibilities:

  • Identify the manufacturing process defects (scrap, non-conforming material and customer complaints) by dispositioning non-conforming material, identifying primary root causes and suggesting corrective and preventative actions. May be responsible for querying and bounding data to support implementation of basic product stops.
  • Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members.
  • Develops process monitoring systems by identifying critical process steps applying methods to reduce process variation in order to reduce/eliminate the cause of defects.
  • Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development.
  • Assists in creation of quality tools and training materials by understanding the limitations of existing quality tools and training materials and by helping to identify more effective tools and materials.
  • Participates in validation activity Role may very between providing input to owning activities such as protocol/report writing and managing execution of validation actives.
  • Participates in corrective and preventative action activity.

Minimum Qualifications and Experience:

  • National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline and 5+ years of related work experience.
  • Wide application of technical principals, practices and procedures. Strong understanding of business unit function and cross group dependencies knowledge and application of concepts, practices and procedures.
  • Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
  • Works on problems of diverse scope where analysis of situations or data requires a review of identifiable factors
  • Establishes and cultivates an extensive network of support to facilitate completion of assignments.
  • Plans, organised and prioritises non routine tasks with approval.
  • Exercises judgement in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.
  • May provide work direction and guidance to varied levels of employees.

2019-225 - Senior Molding Engineer - Clonmel

Description:

Plays a leading role in the area of injection molding related activities, including new tool qualifications and resolution of supply and quality issues encountered during day-to-day running of the business.

Responsibilities:

  • Responsible for design, development, implementation and ongoing support of polymer-based injection molded components used in the manufacture of our client’s products offerings.
  • Serve as both technical expert in the field of injection molding as well as a project manager for molding related projects, working regularly with Research and Development (R&D), Operations, Supply Chain, Quality and suppliers.
  • Manage molded commodities over life cycle including tactical and strategic activities to support ongoing business such as product, process, quality and cost improvement initiatives, supplier and resin changes, material obsolescence.
  • Troubleshoot molding issues in conjunction with supplier and lead/support internal investigations as required.
  • Work closely with molding suppliers to ensure reliable supply of parts.
  • Responsible for ensuring adherence to quality system through creation and update of specifications, metrology, setup, design control and qualification and Failure Models and Effects Analysis (FMEA)
  • Identify critical dimensions and work with suppliers to ensure proper process controls are in place.
  • Must have proven ability to participate in team atmosphere, exhibit and create a sense of urgency and maintain effective working relationships with peers, customers and suppliers.
  • Concurrent management/support of multiple projects.
  • Create and maintain project schedules, lead and participate in cross-functional team activities to achieve program objectives.
  • Transfer of molds to new suppliers, start-up of new suppliers.
  • Participate in cross-functional teams to investigate and resolve molding issues.
  • Perform capacity analysis for molds, presses and assembly automation and make recommendations for future investment.

Minimum Qualifications and Experience:

  • Experience/Education
  • National Framework of Qualifications (NFQ) Level 7 qualification in a relevant discipline
  • 4+ years of relevant work experience or an equivalent combination of education and work experience.
  • Technical/Business Knowledge (Job Skills)
  • Wide application of technical principles, practices and procedures within the field of polymer component manufacture, in particular within the field of injection molding. Strong understanding of business unit functions and cross group dependencies/ relationships. Will perform role within quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
  • Cognitive skills
  • Works on problems of diversive scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of various technical alternatives and their impact.
  • Influence/Leadership
  • Establishes and cultivates an extensive network of support to facilitate completion of assignments. Participates in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel. May lead a project team. Participates in determining goals and objectives for projects. Influences middle management on technical or business solutions. Interacts frequently with suppliers.
  • Planning/Organization
  • Plans and organizes non-routine tasks. Initiates or maintains work schedule. Establishes priorities of work assignments.
  • Decision making/Impact
  • Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure or resources.
  • Supervision Received
  • Works under only general direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.
  • Supervision Provided
  • May provide work direction and guidance to exempt and/or skilled non-exempt levels of employees; may be asked to evaluate performance of and assist in career development planning for subordinates.

Senior Quality Engineer (R&D) – Waterford City

Description:

Ensure that all required Quality systems are implemented and effectively operating in the R&D development Lab. Ensure that all R&D project activities are carried out in compliance with the requirements of Quality Systems, FDA and other regulatory agencies up to and including Process validation. Provide oversight for Design Management of contact lenses – from a Quality System and technical perspective. Provide Quality Support to Manufacturing Plant as required.

Responsibilities:

  • Support Development Lab activities from a quality systems perspective
  • Implement and effectively maintain compliance with regional directives and procedures across R&D activities
  • Review and approve all protocols and reports for R&D equipment qualifications
  • Review and approve all protocols and reports for the manufacture of Clinical Trial Materials
  • Review all batch history records for clinical trial materials prior to issuing QA Release memo
  • Provide Regional Quality support for all Design Control activities
  • Drive and oversee all Risk Management activities for new product development
  • Complete and provide Risk Management and Complaint data updates to Annual Product Quality
  • Reviews and for revision of Design Risk Analysis and Clinical Evaluation Reports
  • Review and approve all Process Validation protocols and reports for new products

Scope of Position:

  • Ensuring that Quality systems are effectively implemented and maintained in Waterford R&D
  • Ensuring Compliance with quality standards and GMP requirements for all product/ process development activities in the R&D program of work through participation in R&D process development teams and approval of protocols.
  • Regional Quality support for all Contact Lens development projects in Waterford from inception to successful technology transfer / scale-up.
  • Risk management activities through development and product lifecycle.

Minimum Qualifications and Experience:

  • Bachelor degree in Science or Engineering
  • Certified training in Quality Systems Requirements of FDA and ISO-13485
  • Certified training in Auditing of Quality Systems
  • Documented training in all relevant company Directive and Procedures
  • 5+ years relevant experience in a similar industry