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.


WATCH PROMO VIDEO

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

9487 - CSV 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.
  • Usual place of work will be in Carlow, Ireland. The successful candidate may sometimes be required to attend meetings at other company sites or off-site.
  • Fluent in English, written and verbal.
  • Previous experience working with the company will be advantageous.

 

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

 

8825 - Health and Safety Specialist - Dublin

Responsibilities:

  • Under the direction of the Site EHS lead, serve as site EHS representative during mechanical completion, commissioning and qualification activities – part of the project walk-down and start-up team for assigned systems.
    • Ensure that installation is in conformance with PHA recommendations, design intent, local and national regulations and internal company standards.
    • Ensure that all necessary procedures, PPE, signage and training are complete and available for performing the necessary tasks during the specific start-up phase.
    • Serve as primary EHS reviewer for Pre-Start-up Safety and Environmental checklists completed during project start-up activities.
  • Under the direction of the Site EHS lead, develop procedures to support the implementation of EHS programs at the Dublin site in accordance with local and national regulations and internal company standards.
  • Serve as a role model and leader in demonstrating and implementing a healthy and strong EHS culture across the entire Dublin site.

 

Minimum Qualifications and Experience:

  • Bachelor’s degree in Engineering or related Safety or Environmental field of study
  • 4+ years of EHS, Engineering, or Operational experience in chemical, pharmaceutical, biochemical, petrochemical or process related industry.
  • Drive to engage others and have excellent interpersonal, communication and leadership skills
  • Be able to maintain focus on the key project goals and priorities, but also be able to dive into the detail to facilitate problem resolution and ensure project success
  • Knowledge and experience working with EHS regulations.

 

9417 - Maintenance Engineer - Cork

Responsibilities:

  • Knowledge of GMP Environment.
  • Lead equipment breakdown investigations.
  • Ensure spare parts are linked correctly to the parent equipment.
  • Ensure correct spares are in stock.
  • Through data analysis and work with the craft teams identify re-occurring equipment issues and implement corrective plans.
  • Work with the projects team to ensure maintenance and reliability are considered as part of the design phase.
  • Introduce predictive maintenance techniques where they add value.
  • Proven record of co-ordinating, leading and implementing FMECA (Failure Modes, Effects and Criticality Analysis) studies for process equipment.
  • Proven track record of reviewing and simplifying PM’s through PM optimisation programme.
  • Knowledge of root cause analysis techniques for equipment troubleshooting and implementation of correctives actions.
  • Knowledge of process and utilities equipment.
  • Participate in engineering team initiatives on an as needed basis.
  • Ensure that the company’s quality and engineering standards are adhered to.
  • Ensure compliance to the company’s Global Engineering Standards.

 

Minimum Qualifications and Experience:

  • 3+ years process / project management experience with a degree in chemical or mechanical engineering.
  • Chartered Engineer an advantage but not a requirement.
  • Must have a good appreciation for designing systems within a GMP environment.
  • Must have a thorough understanding and application of engineering principles, concepts, industry practices and standards.
  • Must be able to provide solutions to moderately complex to semi-routine problems.
  • Must have the ability to recognise deviations from accepted practice as required.
  • Must be able to apply knowledge of current Good Manufacturing Practices (cGMPs).
  • Must be able to exercise judgement within generally well-defined procedures and practices to determine appropriate action.
  • Must be able to work under own initiative and remove road blocks.
  • Normally receives no instruction on routine work and general instructions on new assignments.
  • Strong verbal, technical writing, project management and interpersonal skills are required.

 

9443 - Operational Excellent Specialist - Cork

Purpose:

Support site to deliver significant business results. To improve business processes and build lean capability. Provide leadership and guidance on the integration of Lean & Six Sigma, Change Execution Methodology (CEM), Behavioral Coaching & Consequence Management (BCCM), Inclusion and Process Management systems to achieve business objectives.

 

Responsibilities:

  • Drive the design, management and improvement of site operating systems, management systems and leader behaviours in line with site hoshin.
  • Apply lean principles to recognize and implement continuous improvement activities to increase flexibility, eliminate waste, while improving flow to internal and external customers.
  • Coaching & Execution of Scientific Problem Solving
  • Ensure the highest Quality, Compliance and Safety standards
  • Sound financial stewardship, management and control.
  • Responsible for driving a culture of Continuous Improvement by deploying company Six Sigma tools within the Planning & Logistics group

 

Minimum Qualifications and Experience:

  • Degree or 3rd level qualification (Science, Engineering, Supply Chain, Business Systems).
  • At least three years’ experience in the Pharmaceutical industry or a similar operating environment with experience in a planning role in an operations environment.
  • 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.
  • Demonstrated leadership and change management skills with a continuous improvement focus.
  • Desirable evidence of Continuous Professional Development.
  • Desirable for Lean Six Sigma Green Belt.
  • Knowledge of Business Information Systems
  • Demonstrated ability to fully realize improvement initiatives.
  • Demonstrated successes in a team environment, such as project teams, Six Sigma team, etc.
  • Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.

 

2019-238 - Buyer Planner - Waterford City

Purpose:

Support supply chain function for packaging and raw material requirements. Schedule finished lenses and mould inventory on designated product families. Support indirect procurement activities as required.

 

Responsibilities:

  • Procuring packaging and raw material requirements
  • Issuing RFQ’s, negotiating pricing and contracts
  • Process purchase requisitions
  • Procurement of Capital and Indirect materials as required.
  • Schedule finished lenses and mould inventory on designated product families

 

Minimum Qualifications and Experience:

  • Educated to Degree level – Business / Procurement – or equivalent combination of Education / Experience
  • IIPMM / APICS desirable
  • Strong numerical and analytical skills
  • Ability to use Excel at an advanced level and understanding of ERP LX / JDA or similar ERP systems
  • Focused on Customer Service and delivering Key Operational Measurements
  • The capacity to work on own initiative. Results focused and demonstrates financial and analytical acumen.

 

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.

 

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

 

9399 - Project Manager - Cork

Purpose:

The Project Manager will provide project execution support and expertise to the Supply Chain Function and other site colleagues to manufacture quality pharmaceutical products in accordance to meeting the company Priorities of: Compliance, Supply, Strategy and Profit Plan. The team working style is one of collaboration, coaching and facilitating to provide engineering solutions to the team to support a High-Performance Organization. This individual will be a part of a newly formed Project Management Office (PMO) department 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, Data Integrity, Technical Programs. 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:

  • Responsible for project oversight and control activities, including, definition of scope, business case development, business requirements definition, milestone identification, project governance, operational planning, risk identification & mitigation, implementation planning, project execution oversight and project closure
  • Responsible for ensuring that projects are delivery on time, to agreed level of quality and within approved budget
  • Oversite & control for project cost management through the project life cycle
  • Delivery of effective & accurate project progress reports that can be analysed and understood at all levels within the organisation
  • 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
  • Responsible for project delivery risk and issue management, including the identification and implementation of risk and issue mitigating actions
  • Motivate a multi-disciplinary team to achieve project objectives, through driving the team’s performance so that every individual understands their individual contribution and how it impacts the site
  • Supporting other site project managers to develop standard reporting templates and KPIs
  • 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
  • Ensure there is a strong safety culture and performance in the execution of projects
  • Lead teams providing on-going coaching and support to all team members, including the identification and development of key talent and skills within the site
  • Sound financial stewardship, management and control
  • Ensure highest Quality & Compliance standards. Participate and Comply with the company Quality Management System
  • Support the development and running of the Project Management Office on site

 

Minimum Qualifications and Experience:

  • Appropriate 3rd level or engineering trade qualification
  • A minimum of eight to ten years of relevant experience in project delivery of a broad spectrum of projects in the Pharma industry preferably including experience managing and scheduling Supply Chain projects
  • Knowledge of and experience in applying Lean Six Sigma and Lean methodologies and Engineering excellence through OEE, predictive maintenance planning
  • Demonstrated leadership skills with a continuous improvement focus
  • Project management qualification such as Project Management Professional etc
  • Lead six sigma experience is essential, minimum yellow belt, preferable green belt
  • Demonstrated ability in holding project team members responsible for results and being decisive about non-performers
  • Demonstrated ability to realize improvement initiatives
  • Demonstrated successes in a team environment, such as project teams, Six Sigma team, PITs etc.
  • Demonstrated high level of problem solving and facilitation skills
  • Experience with Management Systems such as PM, EHS, Trackwise, SAP , PRINCE, Microsoft PM etc
  • Stakeholder management of multi decision makers, colleagues, peers and cross functional teams
  • A proactive and intelligent individual who is quick to grasp new ideas and concepts and perform effectively under pressure and changing circumstances
  • 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 are
  • Desirable: evidence of Continuous Professional Development

 

9380 - Process Engineer - Cork

Purpose:

The IPT/CoE Process Engineer will provide operational process support and expertise to the IPT/ CoE to manufacture quality pharmaceutical products in accordance to meeting the company Priorities of: Compliance, Supply, Strategy and Profit Plan. The team working style is one of collaboration, coaching and facilitating to provide engineering solutions to the IPT/CoE team to support a High Performance Organisation.

 

Responsibilities:

  • Accountable for supporting the smooth running of the IPT value stream.
  • Responsible for actively participating in the Tier process to manage Engineering projects and proactively resolve issues before they impact the business priorities.
  • Be an active member within the cross functional IPT/CoE Team providing support, guidance and strive for Engineering excellence to ensure the success of the IPT/CoE. The IPT/CoE Process Engineer will model the company Leadership behaviors and understand the MPS principles to drive a culture of continuous improvement building a High Performance Organisation.
  • Participate and comply with the company Quality Management System (QMS) requirements, including ownership, as relevant to you.
  • Provide ongoing coaching and support to cross functional team members, to share Engineering best practices.
  • Ensure supply of high quality product through ensuring equipment availability, maximise performance through OEE and continuous process improvement initiatives.
  • Sound manufacturing/Engineering stewardship, equipment resource planning, maintenance scheduling and control. For example shutdown activities, vendor management, change control.
  • Ensure highest Quality & Compliance standards.
  • Provide Engineering expertise within a wide range of projects within the IPT/CoE, such as the introduction of new equipment, improvement to the filling process etc.
  • Responsible for supporting a culture of Continuous Improvement by deploying company Six Sigma tools within the IPT/CoE.

 

Minimum Qualifications and Experience:

  • Appropriate 3rd level or engineering trade qualification
  • At least three years experience in the Pharmaceutical industry or a similar operating environment with experience in an Engineering/Process role in a manufacturing environment.
  • Evidence of Continuous Professional Development.
  • Six Sigma Yellow Belt.
  • Project management qualification such as Project Management Professional etc.
  • Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Engineering, Manufacturing, Process etc).
  • Knowledge of and experience in applying Lean Six Sigma and Lean methodologies and Engineering excellence through OEE, predictive maintenance planning.
  • Demonstrated leadership skills with a continuous improvement focus.
  • Project Management Experience leading projects
  • Process and technology background: the successful candidate will understand how to drive optimization and OEE.
  • Demonstrated ability in holding project team members responsible for results and being decisive about non-performers.
  • Demonstrated ability to realize improvement initiatives.
  • Demonstrated successes in a team environment, such as project teams, Six Sigma team, PITs etc.
  • Demonstrated high level of problem solving and facilitation skills.
  • Experience with Management Systems such as PM, EHS, PRINCE, Microsoft PM etc.
  • Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.

 

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.

 

9385 - Planner & Scheduler - Dublin

Purpose:

The Project Management Office (PMO) is in the process of preparing and enhancing current team to define, coordinate and manage the execution of our new Biologics facility start up operational readiness activities. With your help we will ensure success by clearly defining and tracking the activities and/or steps required to meet our Start Up and Manufacturing milestone dates. On this role, you will work with other teams to ensure our startup strategy is ready to be used and deployed during and post facility OQ through commercial manufacturing.

 

Responsibilities:

  • Be part of the team that maintains and drives adherence to the Operational Readiness schedule in collaboration with all the site functional areas and other company support teams.
  • Drive the Operational Readiness activities identification, definition and scheduling in support to the company Biotech Dublin start up.
  • Be responsible for building the process, toolkits /checklists, and schedule required by the team to actively carryout a succesful start up of the facilities.
  • Lead and develop core planning meetings, with the necessary agenda, input and outputs.
  • Ensure effective planning, common understanding and delivery targets to achieve business requirements and incorporate data generated into the planning system.
  • Liaise with various company internal and external stakeholders to develop plans with a medium to long -term forward view, and associated daily delivery plans. Identify Key Deliverables to use in the planning function for each program. Monitor, track and Communicate plans and progress to management.
  • Collaborate with global planners and site leadership to set long term execution plan
  • Drive visible performance management, use KPI’s to track progress, report out using Ms Excel and Power BI, monitoring actual performance versus plan promoting awareness to drive improvement.
  • Develop, model and implement strategies to improve scheduling capability and adherence and integration with other project phases.
  • Lead the integration of CQV and operational readiness project schedules via Primavera P6, MS Project and MS Excel.
  • Collaborate with GES/JV and company teams to achieve commissioning completion, transition and initiation of batch production
  • Critical path analysis and scenario production for time reduction within critical path
  • Reporting of project progress, schedule opportunities and impact to management.
  • Identification and reporting of threats to schedule on weekly meetings
  • Manage and oversee finite production scheduling, including progress reporting & issue escalation.

 

Minimum Qualifications and Experience:

  • S. in Science, Engineering, Computer Science or Project Management.
  • 3-5 years of experience and knowledge in Biologics manufacturing and new facilities start up.
  • Demonstrated ability to manage multiple priorities against ambitious timelines. Strong planning ability
  • Strong problem-solving skills and ability to work cross-functionally as critical member of site team
  • Experience of working in a Project Management environment.
  • Good skills in understanding of non-functional requirements of a given functional area to be able to classify and have similar discussions related to requirements with relevant teams.
  • Good experience in leading Waterfall/ agile projects.
  • Analytical & Decision-making skills: In this role, one would be required to assess a Projects scope, challenges or issues that might come up, issues/risks that can be avoided, impact of the changes raised which may require sound analytical and prompt decision making skills. The role possesses & requires critical thinking skills and the ability to quickly identify and understand where there are activity gaps in the schedule to direct or propose changes to minimize any issues or risk.
  • Should be proficient with MS Word/PowerPoint/Visio/Microsoft Project/Excel/Power BI to create data analytics, documents and presentations
  • Must have Primavera P6
  • Desirable to have Microsoft BI
  • Experience working in teams.

 

9396 - Health & Safety Specialist - Cork

Purpose:

An exceptional opportunity for an experienced Safety & Environment Specialist to join the Environmental Health & Safety (EHS) team; where they will play an integral role in developing, maintaining and continually improving the EHS systems at our vaccines and biologics facility in Cork. They will provide technical guidance to the organisation to ensure compliance with legal requirements related to EHS as well as company corporate standards, policies, procedures and guidelines related to EHS and industry best practices. They will ensure, in conjunction with the EHS team, that all EHS regulatory requirements on the site are upheld to the highest standard.

 

Responsibilities:

  • Develop and implement EHS programmes to ensure compliance with local legislation, company standards, our environmental licences and industry best practices including programmes such as: waste, air and water management, incident investigation, chemical management and emergency response.
  • Ensure that all environmental licence requirements are met.
  • Assist all departments in achieving and establishing compliance.
  • Demonstrate leadership and a strong desire to protect employees, our community and the environment – leading with a ’safety first’ mindset.
  • Prepare reports to site, divisional and/or corporate management and regulatory agencies.
  • Evaluate all EHS applicable requirements for any new projects and processes (along with other site departments where necessary) as well as changes in the existing processes and installation.
  • Conduct annual site self-assessments, and more frequent operating unit assessments, tracking and directing follow-up activities to correct any non-conformity.

 

Minimum Qualifications and Experience:

  • Primary Bachelor’s Degree in EHS or Technical Primary Bachelor’s Degree with a post-grad EHS qualification is required.
  • 3+ years’ EHS experience in Pharmaceutical, or other highly regulated industry.
  • Proven track record of success in the EHS sector.
  • Experience on supporting multiple activities/projects.
  • Technically strong; with understanding and experience of environmental licences.
  • Ability to influence others across Departments.
  • Innovative & Compliance-minded, with the drive to go seek out necessary information.
  • ‘Safety First’ mind-set.
  • Self-directed, capable of using own initiative to make EHS improvements.

 

9407 - Health and Safety Specialist - Carlow

Responsibilities:

  • Participate in project design reviews and HAZOPS for proposed new systems
  • Ensure management of change processes are followed and serve as EHS reviewer for planning of activities impacting existing facility operation
  • Serve as a site EHS representative during mechanical completion, commissioning and qualification activities, participate in project walk-downs and start-up activities for assigned systems:
  • Ensure that installation is in conformance with local and national regulations, internal company standards, design intent and HAZOP recommendations
  • Ensure that all necessary procedures, PPE, signage and training are complete and available for performing the necessary tasks during the specific start-up phase
  • Serve as primary EHS reviewer for Pre-Start-up Safety and Environmental checklists completed during project start-up activities
  • Serve as a leader in demonstrating and implementing a strong EHS culture across the project

 

Minimum Qualifications and Experience:

  • Bachelor’s degree in Engineering or related Safety or Environmental field of study
  • +5 years of EHS, Engineering, or Operational experience in chemical, pharmaceutical, biochemical, petrochemical or process related industry
  • Ability to maintain focus on key project goals and priorities, but also analyse the detail to facilitate problem resolution and ensure project success
  • Knowledge and experience working with EHS regulations
  • Ability to influence both horizontally and vertically

 

9285014 - QC Micro - Dublin

Purpose:

The QC Microbiology Analyst will support start-up of the Bulk Drug Facility in Dublin. The role will particularly focus on cleaning validation with emphasis on TOC method validation and routine testing of Cleaning Validation samples.

 

Responsibilities:

  • Ensuring high cGMP, GLP standards are maintained while testing and adherence to schedules and targets to meet regulatory and business requirements.
  • Compiling protocols and reports.
  • Validation of TOC methods to support cleaning validation activities on site.
  • Support testing of Microbiology and TOC samples on a routine basis.
  • Review and interpretation of test results and trends
  • To ensure a high standard of housekeeping and safety is maintained in the Laboratory.
  • To keep management updated on issues arising within the laboratory.
  • To participate in the training of QC and Manufacturing colleagues as required.
  • Investigate out of specification/limit results in conjunction with the Microbiology Laboratory Supervisor, QA and other relevant departments

 

Minimum Qualifications and Experience:

  • Degree in Microbiology or related science.
  • Technical competency in microbiology and/or analytical method validation.
  • Ability to develop collaborative relationships with other functions and sites in order to achieve functional, site and company goals.
  • Problem solving and root cause analysis skills

 

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.

 

9381 - Projects Engineer - Cork

Purpose:

The role of the Projects Engineer is to Project Manage and Task Supervise Projects in our client’s Cork 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: Acting as the site Standard Owner for Refrigerant Compliance and act as SME for all site Projects which involve Refrigerant Equipment. Assist EHS with tracking Refrigerant addition/removals and maintaining the Refrigerant Equipment Master list on site. Deliver Refrigeration and other assigned projects 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 Projects Engineer will report to the Engineering Projects Lead and will work closely with Area owners and Permit issuers. He/she will ensure all RAMS and Permits are correctly populated and approved for Project Works.

 

Responsibilities:

  • Assist in the development of a Site Refrigerant Strategy.
  • Manage Refrigeration Preventative Maintenance records to site Procedure.
  • Develop project plans and successfully execute them according to established schedule, cost and performance standards.
  • Update of site Preventative Maintenance on SAP for site Refrigerant Equipment.
  • 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/GES run Projects 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.
  • Use Lean principles across all technical aspects of the process, by deploying company Six Sigma tools.
  • Responsible for driving a culture of Compliance and delivery on time.

 

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 especially aware of current Refrigerant EU Regulations.
  • Proven track record in delivering Projects
  • Advanced PC skills such as Excel, Word, PowerPoint, MS Project or Primavera (SAP, MIDAS, TRACKWISE use experience also an advantage)
  • High level of knowledge of Safety, Quality and Environmental requirements.
  • Experience with Qualified Areas Change Control an advantage.
  • 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.
  • Demonstrated successes in a team environment, such as project teams.
  • City and guilds 2079 Qualification an advantage.

 

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.

 

9374 - Clean Utilities Engineer - Cork

Purpose:

The purpose of this role is to be a clean utilities Engineer supporting the Vaccines Integrated Process Team. This is a key role to ensure that the day to day operations of the Utilities provided to the IPT are compliant.

Responsibilities:

  • The primary focus of the position is on GMP/clean utilities and operations (WFI, Purified Water, Clean Steam, Reverse Osmosis, Process Gasses, and HVAC systems).
  • Be responsible for adherence to site and corporate QMS for clean Utility Systems
  • Point of contact for Quality Alerts and Bulletins for Utility Systems. Review and prepare formal responses.
  • Complete periodic reviews and other compliance documentation aligned with the site QMS.
  • Review and approve Utility & HVAC modifications, change requests, and SOP’s.
  • Conduct life cycle analysis of all critical system equipment to ensure equipment is upgraded and replaced in accordance with the Site Master Plan
  • Represent the Utilities engineering group and lead highly technical cross-functional teams and work across utilities engineering areas to deliver robust and sustainable solutions and business processes.
  • Support audits on clean utility systems.
  • Drive functional commitments on initiatives and provide high level of oversight and coordination to seamlessly integrate utility engineering efforts within the site.
  • Consult with other subject matter experts to ensure design solutions achieve long term business objectives and are supported by robust technical rationale to withstand scrutiny.
  • Act as the utilities engineering expert and technical consultant to management in identifying opportunities, prioritizing work and will make sound recommendations for design and construction solutions.
  • Use Lean principles to deliver a cost efficient operating model for commercial production while not compromising EHS and Quality standards.
  • Coaching others by sharing your skill-set and expertise.

 

Minimum Qualifications and Experience:

  • Degree qualification (Mechanical/ Process and Plant Technology/ Chemical Engineering).
  • 2/ 3+ Yrs Pharmaceutical Industry Experience working in a similar.
  • Experience of working with multi-disciplined teams.
  • Good Written and verbal communication skills.
  • Identify key stakeholders and develop a relationship of trust.
  • Solid engineering and business acumen.
  • Demonstrated capability to communicate effectively across multiple teams
  • Lean Six Sigma qualification or experience of application of Lean principles is an advantage.
  • Good knowledge of GMP / FDA regulatory requirements and current Health and Safety Regulations legislation.

 

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

 

9094 - Documentation Controller - Carlow

Purpose:

We wish to appoint a Post OQ / operational readiness documentation controller for a large Fill Finish project located in Carlow. Reporting to the Program Manager, the Post OQ / operational readiness documentation controller is a site-based role.

 

Responsibilities:

  • Provide project documentation control for a company project including management of Drawings, engineering handover documentation, CAD files, CQV files, Site SOPs, Maintenance Plans.
  • Ensuring on-time delivery of documentation deliverables.
  • Manage and control engineering handover documentation from equipment vendors
  • Manage and control Commissioning, Qualification and Validation (CQV) files.
  • To ensure that all work carried out is in compliance with the required standards, conforming to company GDP, cGxP, SOPs, regulatory regulations and guidelines.
  • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  • To perform additional team tasks as agreed to support the project.
  • To assist in the preparation for internal / customer/ regulatory inspections.
  • Compilation and issue of weekly / monthly progress reports & graphics.
  • Management of progress updating interface with Post OQ team weekly and monthly.
  • Planning, preparation and facilitation of key Documentation workshops and communications.
  • On-going liaison with the Project Manager and wider Project team regarding documentation issues.
  • Attendance and input at Post OQ progress meetings

 

Minimum Qualifications and Experience:

  • Minimum of a third level degree in a relevant discipline.
  • 8 years’ experience In project or operations Doc Control with at least 3 years’ experience on Fill Finish Projects (Ideally in a Post OQ Role).

 

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.

 

9116 - Program Manager - Cork

Purpose:

The Program Manager will provide program and project management expertise to the company’s Cork site which manufactures quality pharmaceutical products in accordance with the company’s 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 programs 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 program management support in a High-Performing Organization. This role will require a substantial amount of time within the program/project management process, engaging and communicating with Project Leads and ensuring projects within each program are delivering accordingly.

 

Responsibilities:

  • Responsible for program oversight and control activities, including definition of scope, business case development, requirements & milestone identification, governance, operational planning, risk identification & mitigation, implementation planning, execution oversight and closure.
  • Responsible for the creation and control of plans for departmental, cross departmental, and company-wide programs
  • Responsible for ensuring that programs are delivered on time, to an agreed level of quality and within approved budget and scope.
  • Delivery of effective & accurate progress reports that can be analysed and understood at all levels within the organization.
  • Responsible for stakeholder management, both internal and external, to ensure effective delivery of program objectives, including escalation management.
  • Responsible for identification of risks and issues and the implementation of mitigating actions.
  • Oversight & control of program cost management throughout the life cycle, and continually providing sound financial stewardship and control.
  • Motivating a multi-disciplinary Project Lead team to achieve program objectives, by driving performance so that everyone understands their contribution to the program and how it impacts the achievement of the site’s objectives.
  • Providing on-going coaching to Project Leads, including the identification and development of key talent and skills within the site.
  • Supporting site Project Leads to develop standard reporting templates and KPIs.
  • Ensuring there is a strong safety culture and performance in the execution of programs and 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 program/project management qualifications.
  • Evidence of Continuous Professional Development
  • A minimum of eight to ten years of relevant experience in delivery of a broad range of programs, preferably in the pharmaceutical industry.
  • Knowledge of and experience in applying Program & Project Management tools & techniques within 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.
  • Excellent facilitation, communication and management of senior level stakeholders and other cross-functional leaders.
  • Demonstrated ability in holding Project Leads accountable for project delivery and being decisive about non-performers.
  • Competency developed in people change management .
  • Understands the typical program and project life cycles in a strongly regulated GMP environment and has significant proven experience in this area
  • Demonstrated successes in a program environment, such as multiple project teams, Six Sigma teams, PITs etc.
  • Excellent interpersonal skills and an understanding of the customer/client relationship involved in project delivery
  • 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.

 

9050 - 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 Process Engineering Team to act as client 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’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.
  • 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’s 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 Automated Parts Washing, Autoclaving, Buffer Preparation, Formulation, Single Use Technology, 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.

 

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.

 

8901 - Equipment Engineer - Dublin

Responsibilities:

  • Ensure compliance to all regulatory GMP, Safety and Environmental requirements.
  • Participate in Mechanical Completion walkdowns.
  • Support Commissioning and Qualification activities
  • Collect data and develop maintenance job plans for equipment and systems.
  • Develop SOP’s and Work Instructions for Maintenance of Equipment.
  • Develop Safety Risk Assessment.
  • Participate in FMEA exercises with support from other functions. Document results and input data into appropriate repositories – make recommendations for improvements.
  • Optimise work tasks, collect spare parts, tools or other services requirements.
  • Liaising with project hand over team to ensure that the correct information is captured.
  • Assist with development of technical Training Materials.
  • Running applicable reports and pulling documents together for meetings and audits.

 

Minimum Qualifications and Experience:

  • Level 8 Qualification in Engineering discipline or equivalent.
  • 2+ years’ experience in a process plant or other industry in a maintenance or operations support role.
  • Self-motivated with high attention to detail.
  • Strong communications, organizational and analytical skills.
  • Attention to detail.
  • Experience of reading P&IDs, Construction and Mechanical / Electrical Drawings Desirable.
  • Experience of using SAP or Other Computerised Maintenance Systems.
  • Experience of developing Safety Risk Assessments.
  • Previous experience of FMEA’s – setting up maintenance plans and schedules.

 

9376562 - Specialist Technical Services - Dublin

Purpose:

The Technical Specialist, BDS Technical Services has primary responsibility for providing scientific & technical support of (cell culture derived) drug substance manufacturing processes performed at ADMF, specifically the technology transfer of product(s) into ADMF. The successful candidate will be responsible for providing scientific and technical support through all phases of the product lifecycle, including technology transfer, process scale-up, process validation, routine manufacturing, and process/continual improvement programs. The position requires effective cross-functional collaboration with external contractors and internal partners including Manufacturing, Process Development, Engineering, Regulatory, QC and Quality to provide support of manufacturing of BDS. Previous experience of a technology transfer in a cell culture or protein purification capacity, cleaning validation, and exposure to raw materials specification setting is advantageous.

 

Responsibilities:

  • Provide process information and analysis to facilitate process/facility fit, and qualification of a large scale BDS facility through to NPI tech transfer startup, PPQ validation, in a multi-product BDS facility.
  • Participate in Tech Transfer Receiving Unit activities, and provide technical guidance to team members in large scale cell culture/downstream purification processes, and provide SME support for the area on key audit topics.
  • Provide scientific and technical input to facilitate decision making related to Tech Transfer.
  • Provide/develop deep technical knowledge and understanding in cell culture processes; vial thaw, seed expansion, seed reactors and large scale production bioreactors, including centrifugation and depth filtration steps, or downstream purification processes; large scale column chromatography steps, ultrafiltration/diafiltration steps, pH adjustment, depth/ nanofiltration steps, and final fill.
  • Undertake technical risk assessments to support raw material assessment for NPI, working on Mass balance; development of materials listing/BOM’s to support process.
  • Identify technical issues, and guide resolution of same.
  • Provide SME knowledge and understanding in BDS manufacturing processes (upstream/ downstream); cause and effect, scale up principles, QRM, and process validation strategies.
  • Shape and develop strategy approaches for Technical Services in areas such as cell culture and downstream purification processes, technical studies supporting facility fit and regulatory filings, Technology Transfer, PPQ, CPV approach and so forth ensuring alignment to industry regulations, trends and advances.
  • Ensure current with Regulatory changes, and industry trends, ensuring robust and scientifically sound rationale and justifications applied to company manufacturing processes.
  • Develop and shape standards and strategy documents to support BDS Manufacturing and Tech Transfer.
  • Collaborate with Process Development and Engineering to influence the design and implementation of a robust process control strategy, complete process risk assessments and associated documentation to support equipment qualification activities, PPQ studies and key technical strategies.
  • Engage with internal partners on pipeline processes for manufacturability.
  • Undertake QRM risk assessment per company procedures.
  • Perform risk assessments to support the technology transfer e.g. pFMEA’s and other risk tools.
  • Provide Technical input, review/approval into documentation associated with New Material Introduction, Manufacturing control and enterprises systems (MCS/MES) including manufacturing batch records, work instructions, competencies, and other related Technical documentation.
  • Ongoing technical support of Manufacturing Operations by providing technical expertise for investigation and resolution of process deviations, CAPAs, review and approval of change controls.
  • Requirement to work periodically out of normal business hours (temporary shift working or per out of hours policy) during periods of engineering and validation batch execution, and participation in on-call roster.
  • Short duration Person in Plant (PIP) observation may be required at sending units/existing facilities to support Tech Transfer into ADMF.
  • Author, review and approval of protocols, and reports which may support CMC sections for regulatory agency submissions and responses (as required).
  • Contribute to successful regulatory agency inspections by providing subject-matter expertise on mammalian cell culture/downstream purification, technology transfer and manufacturing processes.
  • Help develop first class technical/scientific staff to maintain a high level of current technical expertise within the Technical Services team.
  • Identify and implement continual improvement initiatives.

 

Minimum Qualifications and Experience:

  • Minimum undergraduate degree in chemistry, biology, engineering or related discipline.
  • An advanced degree (MS, PhD) in Scientific (Biochemistry, Biology, Chemistry, Pharmacy) or Engineering (Chemical, Mechanical) related field is desirable.
  • Minimum of 2-3 years+ experience in a pharmaceutical manufacturing organization, with expertise in Bulk Drug Substance manufacturing, with previous experience in cell culture unit operations or downstream unit operations, process/facility fit, New Product Introduction Technology Transfer. Previous experience of a technology transfer in a cell culture capacity is advantageous.
  • In-depth technical and operational knowledge of multiple unit operations in cell culture processing, centrifugation, depth filtration. Understanding of cause and effect of cell culture metabolism, or downstream processing with chromatography, UFDF, viral filtration and sub-micron filtration, pH adjustment and final fill.
  • Understanding of analytical methods and corresponding signals to enable control strategy development and improvement.
  • Strong understanding of technology transfer, bioreactor scale-up process or scaling principles for downstream unit operations.
  • Comprehensive understanding of cGMP requirements for clinical/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 process/facility fit, design, commissioning and start-up of a bulk drug substance facility is beneficial.
  • Strong interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment matrix organization, and in local group settings.
  • Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form.
  • Can effectively partner with and influence stakeholders without direct solid line authority. Drives technical decisions balancing product quality and operational requirements.
  • Ability to drive for results independently and adapt to rapidly changing priorities.
  • Experience of Technology Transfer activities is advantageous.
  • Knowledge or experience of start-up or systems would be ideal.
  • Excellent communication skills, and able to effectively influence across all levels of the organization both internal and external to the company.
  • Detail orientated.
  • Technical writing competency.
  • Excellent organizational skills with strategic thinking and vision for the group.
  • Demonstrated ability to drive for results and lead innovation and change.
  • Self-driven, able to prioritize, and to orchestrate multiple activities at once.
  • Consistently demonstrate sound business judgment when making decisions.
  • Ability to deal with ambiguity and complexity and influence others across levels of the organization

 

8007 - Health and Safety Specialist - Cork

Purpose:

A vacancy exists for a Health and Safety Specialist at the our client’s Cork site supporting the Vaccine processes on site. Reporting to the EHS Lead, the Safety Specialist will be a key member of the site EHS team providing support, guidance and expertise to their assigned area. The purpose of the role is to implement, audit and advise on company EHS policy to ensure the safe operation of the vaccines plant and the health and safety of its employees.

 

Responsibilities:

  • Promotes culture of EHS excellence in Vaccines and provides high-quality safety leadership to assigned operations.
  • Addresses risk prevention opportunities
  • Conducts assessments, tracking and directing follow-up activities to correct any non-conformity.
  • Creates and maintains databases & records containing pertinent EHS metrics and data.
  • Direct the Vaccines team on EHS requirements to ensure the area is in compliance with EHS Standards and EHS legislative requirements. Provide guidance on these standards where required.
  • Assess changes which have an EHS impact.
  • Engage in walkdowns and reviews to ensure conformance with Site, Corporate and/or Statutory EHS requirements.
  • Assist in the timely response to external and internal stakeholder EHS requests and recommendations.
  • Provide technical support and advice on new processes and equipment.

 

Minimum Qualifications and Experience:

  • Technical primary degree with a post-grad EHS qualification
  • 5+ years EHS experience in an operational environment
  • The successful candidate will be able to demonstrate a proven track record to influence others. Have strong knowledge of safety programs
  • Be a convincing communicator with strong interpersonal skills.

 

 

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

 

 

9081 - QC Documentation Compliance Specialist - Carlow

Purpose:

Our client’s Carlow facility offers a fantastic QC Documentation Compliance Specialist opportunity for candidates interested in a new challenge in a cGMP regulatory environment. We are looking for a QC Documentation Compliance Specialist who will report directly to the QC Compliance Manager and who will liaise with cross functional teams on site, in particular QC Operations and QA Documentation control group. The ideal candidate will have 3-5 years experience in an analytical/ pharmaceutical background. This role will work as part of cross functional team and provide documentation support for the Quality Laboratory. The role will support all laboratory documents including protocols / reports/ SOPs / Test Support Documents/Data Capture Sheets/ Laboratory Logbooks. The successful Specialist will provide technical expertise, trouble-shooting, training and support to the incoming quality team and in addition, will liase with technical subject matter experts from other company sites as well as participate in above site analytical and technical forums.

 

Responsibilities:

  • Provide documentation support for the Quality Laboratory with respect to the following:
  • Support the updating of Standard Operating Procedures, Test Support Documents, Data Capture Sheets, Analytical Standards, protocola and associated reports and any other documentation/ admistration of these documents in direct support to the Quality Laboratories
  • Responsible for reconciliation of laboratory documentation/ Logbooks
  • Logbook control – issuance and archiving
  • Archiving/ retrival of the laboratory documentation in the specific Quality laboratory Archive areas § Maintaining and controlling the Quality Laboratory Archive area
  • Acts as Quality point of contact for all documentation topics
  • Assist in the review of lab operational procedures, training materials and procedures for various systems
  • Support documentation in support of investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications
  • Assist in the management of periodic reviews as required
  • Drive continuous improvement for all aspects of documentation control/ archival
  • Lab representative for all new documentation systems
  • Contribute to the achievements of department productivity and quality goals
  • Provide support with audit/inspection requirements to ensure department compliance/ readiness
  • Liase with site QA Document Control group

 

Minimum Qualifications and Experience:

  • Technical
  • 3 – 5 years experience in a quality role (QC/ QA), ideally in a pharmaceutical manufacturing environments
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
  • Knowledge of cGMP and GDP preferred
  • Report, standards, policy writing skills required
  • Equipment and process validation
  • Sterile filling processes and equipment
  • Proficiency in Microsoft Office and job related computer applications required
  • Lean Six Sigma Methodology experience desired
  • People
  • Good Collaboration Skills
  • Ability to work as part of a team to determine priorities
  • Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance
  • Demonstrated ability to drive the completion of tasks
  • Proven decision making capability with accountability and responsibility
  • Demonstrated ability to solve problems
  • Education
  • Bachelors Degree or higher preferred; ideally in a related Science discipline

 

8888 - C&Q Lead - Carlow

Purpose:

Reporting to C&Q Technical lead as part of a multi-discipline team responsible for Commissioning & Qualification (C&Q) activities on a multi-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, incorporating Black Utilities and Clean Utilities (including CIP).
  • 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.
  • Implement company GES C&Q strategies as set out by the C&Q Manager.
  • 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. Possess good communication skills.
  • 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.

 

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 USP/DSP/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.
  • Experience in C&Q of Black and Clean Utilities
  • Working knowledge of process control systems and automation. DeltaV, syringe & vial line experience beneficial.
  • Knowledge of C&Q documentation required for cGMP process equipment.
  • Fluent in English, written and verbal.
  • Ability to understand project plans and schedules.
  • 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
  • Strong interpersonal and communication skills (verbal/written)

 

9328 - Technical Writer - Dublin

Responsibilities:

  • Track and drive the completion of the documentation package for the start up of the company’s Biotech Dublin Logistics dept.
  • Lead the documentation generation and management of the Warehouse/Dispensary procedures & processes. Leading the related execution of the start up plan for the Warehouse/ Dispensary department for this
  • Be a “go-to” person in the company’s Biotech Dublin Warehouse and Dispensary document control, providing key guidance for documentation related issues
  • Help in the start-up of the Warehouse & Dispensary Operation, helping the team to support with all documentation related issues as it related to C&Q activities, developing processes/SOP and giving input in the development of COMET (SAP), LIMS and MES.
  • As needed by the business, support other related GMP task as needed
  • Create and maintain templates for all required forms & templates within the department
  • Facilitate document reviews with cross functions groups, Engineering, MS&T, QC, QA, etc
  • Implementation corrective and preventative actions which are related to Dispensary, Warehouse & Logistics documentation.
  • Contribution towards Warehouse & Dispensary departments non-conformance/deviation write ups, working with relevant staff members to reach a true root cause and ensure improvements to the processes
  • Contribute toward, promote & facilitate Continuous Improvements and Process improvements within the Warehouse/Dispensary Operations area. Using best practice lean tools and following the company’s Production Systems philosophies.
  • Run required department training needs reports, ensuring that the relevant training is up to date per person, following up with associates to ensure focus on training is given and therefore maintaining a 100% training record for the department.
  • Work with site planners/schedulers in order to aid the area Manager to ensure that that the areas workload is correctly level loaded to maximize efficiency across the project timelines
  • Provide support to the Warehouse & Dispensary department in order to provide a culture of continuous improvement with regard to the on-site distribution of materials to key internal customers, i.e. manufacturing, Labs, MS&T, etc.
  • Generate documentation for training materials to include both the operating principles and also key steps for successful operation; select photographs, drawings, sketches, diagrams, and charts to illustrate material.

 

Minimum Qualifications and Experience:

  • General
  • Demonstrated ability to performed technical documentation writing, i.e. SOP’s FORM’s, batch Records, etc.
  • Capability to interact and communicate with all levels of operational teams and greater Supply Chain team.
  • The ability to influence decision making in a manner that achieves the best possible solution for the organization.
  • Ideally have an understanding of how a Dispensary & Materials process flows work with Supply Chain team that is required to support a manufacturing facility.
  • Possess the ability to communicate with both technical resources and operators to incorporate both the theoretical and practical components for process training.
  • Technical
  • Ability to use electronic documentation systems for review/approval of SOP’s, write up of Deviation/Non-Conformances, etc
  • Experience in key Microsoft packages, Word, Excel, Powerpoint, etc in order to communicate messages to shop floor associates, peers and department leaders.
  • Knowledgeable on use of equipment used in a RM Sampling/Dispensary Operation, i.e. Downflow booths, scales, Fumehoods, drum movers, etc would be a distinct advantage
  • Preference for candidate to have a good knowledge of the overall Drug Substance manufacturing process (Upstream & Downstream processes)
  • Ability to understand technical documentation relevant to tech transfer (process flow diagrams, tech transfer documentation, and master batch records)
  • Review manufacturer’s and trade catalogs, drawings, and other data relative to operation, maintenance, and service of equipment.
  • People
  • Ability to interact with multiple stakeholders across numerous departments
  • Excellent communication skills and the ability to work in a cross functional collaborative environment.
  • Good interpersonal skills, attentiveness and an approachable manner for interactions with inter-departmental colleagues.
  • High degree of problem solving ability and adherence to scheduled timelines.
  • Education
  • Preferably a Level 7 qualification in a related discipline.
  • Knowledge of GMP/FDA regulatory requirements, housekeeping, health and safety.
  • Knowledge of validation an advantage but not essential.
  • Previous experience of working within a Known Consignor approved warehouse 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.

 

9210 - Logistics Specialist - Tipperary

Purpose:

The Logistics Specialist is responsible for ensuring that production campaigns are supplied with raw materials and that all inventories are accurately reflected in the plant inventory system. The Logistics Specialist is also responsible for reporting production data for all operating areas to Financial Services on a monthly basis.

 

Responsibilities:

  • Is responsible for ensuring material review is conducted when each revision of the production schedule is issued. This review includes:

 Review of available materials

 Review of materials approaching Retest/Expiry

 Initiation of resample process by identification of FEFO materials that require retest.

  • Is responsible for ensuring timely request of materials for manufacturing usage.
  • Is responsible for initiation of end of campaign floor counts to ensure the inventory management system reflects the physical material qtys.
  • Revises the Raw Material Storage Plan on a campaign basis for manufacturing area.
  • Ensures that plant Inventory system accurately reflects all inventories and takes actions to correct deficiencies by:

 Adjusting inventory where a process order is closed on instruction from manufacturing

 Identifies material for discard via the IQV process

 Completes inventory adjustment via ZSCM_INTERCOMP at and SU level.

 Adjust solvent levels as instructed by IPT

  • Is responsible for charging solvents to process orders using the Manager Liquid Solvent Report.
  • Ensures that no materials are present in the production area with a Q status.
  • Will complete revenue report for solvent usage (receipts and consumption) for Irish Revenue
  • Completes inter plant inventory transfers and all’s confirms GRs in ID points for finished goods.

 

Minimum Qualifications and Experience:

  • Technical:
  • SAP usage at high level.
  • Business:
  • Understand IPT structure and material management interfaces
  • Incumbents should be organized and methodical with attention to detail and be rigorous in follow-up and resolution of issues.
  • Leadership:
  • Make Rapid, Disciplined Decisions
  • Act with Courage and Candour
  • Demonstrate Ethics and Integrity
  • Drive Results

 

9167 - Facilities Engineer - Carlow

Purpose:

The Facilities Engineer will perform an integral role in the development of the company’s drug product facility. The Engineer will take ownership for the operation and maintenance of the Facility through the outsourced provider (such as, but not limited to, Facility Maintenance, NGMP cleaning, GMP cleaning, Pest Control, Building Maintenance, Breakrooms/Canteen, Landscaping, Warehouse Equipment (Racking/Forktrucks), Laundry/Garbing/Lockers, Security, Waste and Temp. builds/ offsite storage). 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 Facilities 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 Facility 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 Facilities 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.
  • Ensure that all equipment is properly operated and maintained in line with Company standards, local and EU regulations and industry best practice.
  • Implementation of Facilities projects from inception, through to completion.
  • Collaborate cross-functionally with outsourced partners and other departments to successfully complete tasks.
  • 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 Facilities 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 in Facilities Management) 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 Facility management (design, through to sustaining operations; including ARM – asset reliability maintenance).
  • SME in Facilities (Facility Maintenance, NGMP cleaning, GMP cleaning, Pest Control, Building Maintenance, Breakrooms/Canteen, Landscaping, Warehouse Equipment (Racking/Forktrucks), Laundry/Garbing/Lockers, Security, Waste and Temp. builds/ offsite storage).
  • 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’s 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 BioPharma.
  • Evidence of continuous professional development is desirable.

 

9199514 - QA Documentation II - Dublin

Responsibilities:

  • Assessment, coordination and withdrawal of documents within the Electronic Document Management System (eDMS).
  • Collaboration with document owners to facilitate efficient processing of impacted documentation.
  • Generation of queries and reports from eDMS.
  • Interface between Document Control and Training Operations to ensure updated documents are transitioned into the Learning Management System (LMS).
  • Generation, development and communication of project metrics and status updates.

 

Minimum Qualifications and Experience:

  • Sc. in science/engineering with a minimum of 3-5 years’ experience in cGMP Quality environment; or equivalent combination of education and experience.
  • 3-5 years’ experience within the pharma industry or related field.
  • Knowledge of cGMP requirements for documentation control.
  • Direct experience with firstDoc eDMS or similar Documentum-based platform.
  • High level of organization required to plan, execute and track completion of project deliverables.

 

9384815 - Supply Chain Distribution Specialist - Dublin

Responsibilities:

  • Coordination and execution of Finished Packed Product shipments across the company’s Global Network
  • Manage operational logistics to identify, develop, update or maintain sustainable processes to ensure on-time delivery with no interruption to supply across the company’s Global Network
  • Support the supply chain product security network, with responsibility to develop processes
  • Primary contact for stakeholder engagement with the company’s Global Trade function to ensure compliance in import/export processes
  • Manage aspects of the daily compliance requirement which will include the oversight of the quality records metrics
  • Creation of GMP and non-GMP documentation including procedures, specifications and shipping documentation across Global Logistics
  • Primary training representative for Global Logistics
  • Responsible for CAPA’s, Change Controls & Deviations program and initiate Corrective Action plans in the company’s Quality Management System, TrackWise
  • Fully compliant with internal SOP’s, standards and associated training.
  • Identify process improvements within the function and drive the initiative forward to implementation and effectivity
  • Participate and manage projects for continuous improvement related to Global Logistics and Supply Chain
  • Coordinate introduction of new shipping lanes for new and existing products from commercial launch and clinical to commercial activities with validation SME’s
  • Maintain regular and proactive communication with all internal and external stakeholders to ensure efficient execution of schedules.

Minimum Qualifications and Experience:

  • Degree in Business Management, Supply Chain/Logistics, or related field preferable
  • At least 5 years’ working in Pharmaceutical supply chain distribution operations management activity within an international environment is essential
  • Knowledge and understanding of GMP/GDP standards
  • Strong problem solving experience
  • SAP Knowledge of SD and MM Environment
  • Computer literate, with MS Office (Word, Excel, Outlook)
  • Fluency in English both written and oral; fluency in other European languages 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.

 

2019-237 - Buyer - Waterford City

Purpose:

Ensure all Purchase Orders are raised and sent to the supplier in a timely manner. Ensure compliance with all relevant Customs Procedures Day to day procurement/administration activities required to support the Department.

Responsibilities:

  • Ensure all Purchase Orders are reviewed for accuracy and compliance and are sent out in a timely manner
  • Expedite Purchase Orders where required
  • Raise Capital and Indirect Purchase Orders.
  • Raise Special Payment Requests
  • Vendor Management including negotiating pricing with vendors
  • Issue RFQ packages and analyze tender returns
  • Prepare and obtain approval for the set-up of all New Suppliers
  • Monitor all Imports and check paper work on a monthly basis
  • Advise Customs Clearing Agent of any errors & provide classification clarifications when required to our Clearing Agent
  • Run weekly SOX and PO Amendments Reports
  • Manage the Mobile Phone A/C. Manage the introduction of all new handsets and the setting up of new accounts with the Mobile network
  • Ensure SOP’s and Work Instructions are updated in Documentum
  • Ensure Compliance Wire is up to date
  • Prepare and support the Contract approval process
  • Support / Backfill other Procurement activities as required

 

Minimum Qualifications and Experience:

  • Over 3-5 years’ experience working in Procurement in Healthcare industry
  • MRP experience
  • Knowledge of ERPLx is desirable
  • Excellent interpersonal, communication, influence and negotiation skills
  • Demonstrates strong attention to detail, sound judgment and ability to work on own initiative
  • Proficient in problem solving and demonstrate financial acumen

 

Senior Quality Systems Engineer - Waterford City

Purpose:

The primary function of the Senior Quality Systems Engineer is to provide support to the MDR team and ensure all required objectives associated with 2017/745 (MDR) are implemented in the manufacturing plant.

Responsibilities:

  • Assist with the maintenance of the Quality System within the plant
  • Management of metrics on change control, CAPA etc
  • Drive improvement and efficiency within the quality system
  • Implement any Plant Quality system changes as identified by MDR
  • Provide Supplier Quality support to any supplier changes / material changes
  • Work closely with the plant ensuring clear communication of any new Regulations
  • Support risk management, risk analysis and health hazard analysis
  • Assist in the internal audit Programme, preparing metrics and analysis of results following audits
  • Work cross functionally to drive robust corrective actions based on thorough review of complaint data
  • Additional requirements of the job will be specified by the Quality Systems Manage

 

Minimum Qualifications and Experience:

  • 3rd level Qualification in Quality / Science / Engineering with a minimum of 5 years work experience in a Quality Systems Engineering role
  • Experience working with an ISO13485:2016 compliant quality system essential
  • Operational Excellence Training advantageous
  • Self-directed and results driven team player.
  • Ability to work on own initiative, to deadlines, while also capable of working as part of a multi discipline team
  • Strong problem-solving skills and ability to handle multiple tasks in a fast paced environment
  • Excellent interpersonal and communication skills, both written and oral with the ability to work effectively with staff at all levels of the organization
  • Excellent organisational skills, ability to take on and drive a project

 

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.

 

Training and Development Specialist - Waterford City

Purpose:

Working within the HR team, support the Training & Development function ensuring compliance to Learning and Development strategy and requirements across the company’s facility.

Responsibilities:

  • Work as part of the project team to implement, maintain and update the Learning Management System – company LMS
  • System administrator for company LMS
  • Provide ongoing Training support to all areas across the company Campus to ensure compliance to all training and development procedures.
  • Support Area Managers and Team Leads in completing team Individual Training Plans via the Training & Development Process Map
  • Support HR with the Induction training program and carry out training of new employees as appropriate.
  • Support the identification of the campus training needs and co-ordinate the sourcing of approved course aligned to the campus training plan
  • Co-ordinate and support the Leadership Development Programme
  • Liaise with Area Managers & team leaders to continuously improve the training system and ensure they can directly address the development of their direct reports
  • Work with all departments/functions where relevant to support the development of competency-based profiles, training matrices and on the job certifications.
  • Support the completion of all relevant documentation to comply with training & development grant reporting requirements
  • Ensure all new starters / internal movers / graduates have a training plan identified ready for them commencing their new role
  • Design and deliver Training Courses in line with business needs
  • Author/review and approve Learning documentation/material
  • Develop training effectiveness indicators to monitor progress as well as differences between operational areas
  • Ensure effective communication and promotion of training and development activities
  • Identify, support and implement continuous improvement initiatives or projects.
  • Ensure timeliness of CAPA and audit actions
  • Work with Training & Development Controller to set up training, raise vendor PO’s, system administration for EQi etc
  • Participate as part of the HR team including adhoc projects, event management HR & training initiatives, HR communication etc

Minimum Qualifications and Experience:

  • At least 3 years previous experience in a training & development function within a pharma/ manufacturing/R&D environment
  • Extensive Learning Management System experience, preferably Success Factors
  • Significant experience in supporting managers in training & development related requirements
  • Experience in use of training & development tools and systems
  • Computer literate

 

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

 

8788236 - BDS Manufacturing Technologist - Dublin

Responsibilities:

  • Manufacturing Technologists are responsible for Manufacturing Support to the BDS operations in Dublin. They help to build and sustain employee engagement by creating a culture of open, efficient execution and an environment in which individuals and teams can excel and continuously improve.
  • The level 3 manufacturing technologist is a senior role, which requires significant subject matter expertise and provides technical leadership, leading complex projects relating to improvements and investigations within the BDS operations function.
  • Leader and provider of expert technical and documentation support to investigations, CAPA’s, change controls, training and improvement projects ensure the manufacture of bulk drug substance is performed in a safe, compliant, cost effective manner meeting the regulatory requirements defined in relevant health authority submissions, cGMPs and local Health and Safety requirements.
  • During the start-up project and routine new product introductions, the Manufacturing Support team provide end user operations requirements input into design, commissioning and validation of equipment, automation and processes as part of multi-function project teams.
  • The Manufacturing Support team takes a lead role developing Operations procedures, batch records (electronic or paper as required), other documentation and provide technical training to the Operations teams.
  • Manufacturing Technologists take an active role in setting up work practices and procedures that minimize human error, and work with operations continuous improvement teams to remove sources of error.
  • Manufacturing Technologists successfully lead teams to deliver all project requirements associated with cost, time and functionality, ensuring that all KPI targets are achieved.
  • The Manufacturing Support team Develop and maintain strong and effective relationships with partners at the facility including Quality, Engineering, Technical Services, Supply Chain, Regulatory Affairs, Human Resources and Finance. They lead and contribute to best practice sharing with manufacturing and technical colleagues at other company facilities and across the industry.

 

Minimum Qualifications and Experience:

  • Undergraduate degree in science or engineering or equivalent is required
  • A minimum of 8 years’ experience in Manufacturing Operations, Technical Support or Equipment Engineering in a biopharmaceutical company or closely aligned industry
  • Extensive knowledge of biological manufacturing processes
  • Significant experience with leading projects in areas such as media prep, buffer prep, sterile filtration, upstream and downstream unit operations. Experience of formulation, aseptic and sterile manufacturing, including, autoclaves, sterile filtration, Vial and Syringe packaging would be an added advantage
  • Experience of capacity expansion and new product introduction project work is essential and experience of a green field start-up is desirable
  • Experience in investigating complex manufacturing investigations, CAPA’s and Change Controls
  • Good knowledge of GMP/HPRA/FDA regulatory requirements and current Health and Safety Regulations legislation
  • Well-developed analytical, numerical and computer skills and the ability to combine hands-on activities with theoretical knowledge and expertise
  • Good Presenting and Training Skills
  • Good Technical writing skills
  • Excellent communications and decision-making skills
  • Min Green Belt in Lean six sigma
  • Proven ability to work well as part of a team & on own with minimum supervision
  • Proven leadership skills
  • Other duties as 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.

 

8790765 - Document Controller - Dublin

Responsibilities:

  • FirstDoc Coordinator via EDMS System
  • Copy, scan and store documents via Sharepoint
  • Receipt of Vendor and Contractor Turnover Packages
  • Check for accuracy and edit project files
  • File documents in physical and electronic copies
  • Create templates for future use
  • Retrieve files as requested by employees and contractors
  • Manage the flow of documentation within the BDS Project
  • Issue Documentation numbers
  • Updating project procedures and fillable forms
  • Documentation turnover transfer care, custody and control
  • Prepare ad-hoc project reports as required
  • Audit preparation
  • Any other duties as required by management

 

Minimum Qualifications and Experience:

  • 3+ Years’ experience in a similar role is essential for this position
  • Educated to Leaving Certificate standard (or equivalent)
  • Proven work experience as a Document Controller or similar role
  • Familiarity with project management
  • Hands-on experience with MS Office and MS Excel
  • Knowledge of Electronic Document Management Systems (EDMS)
  • Proficient typing and editing skills
  • Data organization skills
  • Attention to detail
  • Well-developed analytical, numerical and computer skills and the ability to combine hands-on activities with theoretical knowledge and expertise
  • Good Presenting and Training Skills
  • Good Technical writing skills
  • Excellent communications and decision-making skills
  • Min Green Belt in Lean six sigma
  • Proven ability to work well as part of a team & on own with minimum supervision
  • Proven leadership skills
  • Other duties as required

 

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.

 

8916439 - IT Project Manager - Dublin

Purpose:

The IT Project Manager for the IT-Global Operations organization is responsible for the planning and execution of IT projects that includes any and all phases of the project life cycle while incorporating the system development life cycle. The Project Manager is accountable for delivering projects on time, within budget, and with high quality. IT Project Manager will work closely with the business teams and various IT functions (e.g. IT Business Partners, Solution Delivery Managers, Architects etc.) to deliver on various business transformation initiatives. This position reports to the IT Portfolio and Project management organization and focuses on the implementation of IT projects within the area of the Global Operations functions e.g. Supply Chain, Manufacturing, Facilities, EH&S.

Responsibilities:

  • Drive proper project chartering and setup.
  • Facilitate the definition of the project scope, milestones, tasks, deliverables and resource requirements.
  • Identify necessary management structures for projects and secure the management involvement required.
  • Estimate project costs and manage the budget (includes related scope control).
  • Establish a communication strategy in partnership with business and IT sponsors and effectively communicate project related information to team members, IT management, and customers throughout the project life cycle.
  • Keeps user experience in the forefront of all user-facing projects.
  • Work with technical teams and business teams when developing technologies and communication plans to provide an optimal end user experience.
  • Drive project management processes (including scope, schedule, risk, issue, resource, and budget management). Develop and maintain project plans, status reports, risk and issue logs, budget/ongoing project forecast of resources and materials and other project related artifacts.
  • Ensure that assigned projects are conducted in compliance with all department standards, policies, and guidelines.
  • Efficiently identify and resolve project issues.
  • Escalate issues that require leadership attention.
  • Responsible for managing and preparing the IT portfolio status report and dashboard for IT-Steering Committee
  • Track project metrics (for example, schedule variances and customer satisfaction) to drive effective project execution.
  • Continually identify, prioritize and mitigate project risks.
  • Perform team management, driving motivation, collaboration and performance.
  • Oversee and control any external resources contracted to the project.
  • Manage vendor relationships and drive deliverables to meet target dates.
  • Ensure business inclusion throughout the management of the project schedule, project decision making, training, etc

Minimum Qualifications and Experience:

  • Bachelor’s degree Business Management and/or Information Technology management, or equivalent
  • PMP certification, or equivalent
  • Minimum 6-8 years’ experience in Business Transformation program and/or Project management area
  • Demonstrated project management skills, with proven track record of leading broad, complex and/or strategic projects combined with the ability to execute at tactical project-level activities and tasks
  • Strong understanding and appreciation of business processes and pain points in the Operations functions, with emphasis on Supply Chain and Manufacturing
  • Experience managing the integration of IT solutions between systems e.g. SAP, Serialization, Manufacturing Execution Systems(MES), Data Lake population & reporting
  • Familiarity with best practices for partnering with SaaS and Cloud-based companies for delivery of compliant, robust systems
  • Strong understanding of SDLC, GxP Regulations and GxP Systems Validation (21 CFR Part 11, Annex 11), with focus on Good Manufacturing (GMP) and Good Distribution (GDP) practices
  • Demonstrated experience with assessing, rating, prioritising and managing IT/Business projects portfolio in biotech and/or pharmaceutical industry
  • In-depth knowledge and experience building and motivating teams, with stakeholders at all levels of the organization
  • Broad business acumen and understanding of software development processes, outsourcing and off-shoring
  • Proven experience working effectively in a matrix organization and ability to collaborate effectively across geographies
  • Integrate process, people, quality and commitment-centric approach to getting work done
  • Drive for high quality and ability to collaborate with other stakeholders to achieve high goals
  • Ability to work with different cross-functional stakeholders to establish and ensure a reliable and productive working relationship
  • Good written and oral communication skills including capacity to comfortably interface with senior leaders, including executive staff
  • Strong negotiation skills and ability to influence

 

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