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


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RECRUITMENT

CLIENT

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

PROFESSIONALS

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

PROFESSIONALS

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

AVAILABLE VACANCIES

Materials Purchasing Specialist - Athlone

Responsibilities:

  • Complete end to end purchasing activities in accordance with applicable procedures, corporate policies, and cGMP requirements for direct and indirect raw materials in support of site Operations.
  • Work with Manufacturing and other site departments to understand future material needs and develop and manage a purchasing schedule.
  • Process purchase requisitions, enter purchase orders in SAP, and generate reports for upper management review.
  • Trend vendor issues and manage supplier performance and KPI’s for business review meetings with vendors.
  • Support Raw Materials and SAP Process teams – identify problems, recommend process improvements, and work with the team on resolutions.
  • Resolve invoice discrepancies by working directly with the vendor, internal requisitioner and corporate Accounts Payable.
  • Work closely with internal stakeholders such as Manufacturing, Planning, Operations, Quality Departments, and Finance and Flag any supply issues as appropriate in a timely manner.
  • Action MRP output as appropriate and manage the Direct Materials Supply Chain;
  • Set up and maintain material master data for existing and new material introductions.
  • Manage the introduction of new material and vendor set up for AAMF.
  • Manage Bill of material’s creation, up keep, changes on an ongoing basis.
  • Weekly release of manufacturing Bills of materials to meet AAMF’s annual production schedule.
  • Track all new material introduction for the Fill finish/Biologics plant ensuring effective timelines/deadlines are achieved.
  • Track Vender change notifications and ensure company policies are followed.
  • Provide Material and Logistical input and oversight for all start-up project activities through to commercial readiness and ongoing product disposition.
  • Ensure incoming inspection activities for all materials and components are completed in line with all GMP and regulatory requirements.
  • Responsible for change controls, deviations and CAPA’s related to Materials and Logistics for the Athlone Facilities.
  • Develop and implement appropriate metrics and key performance indicators.
  • Review and approval of SOPs, master batch records, policies, operational standards, validation protocols and reports to meet the needs of Clinical and Commercial Operations groups.
  • Actively contributes to continuous improvement activities.
  • Lead all environmental material initiatives and material safety related items

Minimum Qualifications and Experience:

  • 3rd level qualification in Business, Materials Management, Operations or Supply Chain Management/Logistics or other equivalent such as APICS qualification.
  • 0 – 3 years of purchasing experience in a Biopharmaceutical or Pharmaceutical environment, preferred.
  • Proficient in use of Microsoft Office suite – Excel, Powerpoint, Word.
  • Understanding of cGMP Raw Material purchasing requirements.
  • Excellent interpersonal and communication skills.
  • Customer service oriented, self-starter, responsible and accountable for scope, and able to work on problems of moderate scope involving various cross-functional groups.

Supplier Quality Engineer - Clonmel

Description:

Provides technical support in the selection and approval of suppliers and service providers by performing supplier evaluations. Monitors supplier performance to drive supplier corrective action. Conducts supplier certification activities. Drives improvement and corrective action in the quality of components sourced from outside suppliers.

Responsibilities:

  • Assesses potential new suppliers and service providers for technical quality and quality systems capabilities. Determines method of evaluation and forwards either a correspondence questionnaire to the supplier or conducts an on-site audit.
  • Prepares and audit report that establishes the outcome of the audit and details the non-conformances identified during the on-site audit. Works closely with suppliers to obtain an appropriate written corrective action response plan with estimated dates for completion. Tracks audit results, including corrective actions and provides follow-up to these actions, as required.
  • Evaluates Exception Reports (ERs) issued for nonconforming supplied material and prepares Supplier Corrective Action Requests (SCAR) to effect resolution of root cause problems contributing to unsatisfactory supplier quality performance.
  • Maintains an active role with new products development teams to assist in supplier selection and approval and provide support, as required. Applies the appropriate engineering discipline to assure acceptable products or services and to resolve quality issues.
  • Prepares data for presentation at the Corrective and Preventive Action (CAPA) meetings summarizing the results and status of corrective and preventive actions initiated with suppliers to strive for improvement.
  • Ensures that the supplier performs and documents the appropriate engineering approach to activities such as qualification/validation and provides assistance in these efforts, as appropriate.
  • Conducts field visits of supplier sites to bring understanding and resolution of quality problems.
  • Uses computer software to measure, track and trend supplier quality performance and provide feedback to the organization and to the supplier for continuous improvement.
  • Conducts certification activities to upgrade approved suppliers to certified supplier status.
  • Notifies suppliers of customer complaints related to device failures resulting from supplied material and requires investigation and corrective action.

Minimum Qualifications and Experience:

  • Experience/Education: National Framework of Qualifications (NFQ) level 7 in a relevant discipline, 2+ years of related work experience, or an equivalent combination of education and work experience
  • Technical/Business Knowledge (Job Skills): Working knowledge and application of business concepts, procedures and practices. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
  • Cognitive Skills: Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Have a general knowledge of technical alternatives and an understanding of their impact on the systems environment.
  • Influence/Leadership: Cultivates a wide range of internal networks and begins to develop an external network of resources to facilitate the completion of tasks. May demonstrate basic project management skills by acting as a project lead on small, well defined projects. Provides guidance to less experienced staff. Influence exerted at peer level and occasionally at first levels of management.
  • Planning/Organization: Plans, organizes and priorities own daily work routine to meet established schedule.
  • Decision Making/Impact: Exercises authority and judgment within defined limits to determine appropriate action. Failure to achieve results or erroneous decisions or recommendations may cause delays and may result in the allocation of additional resources.
  • Supervision Received: Works under general supervision. Receives limited supervision on standard issues and detailed instructions on new assignments. Work is reviewed for soundness of judgment, overall adequacy and accuracy.
  • Supervision Provided: May provide limited 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.
  • The availability to travel both within Ireland and internationally will be required as part of this role.

Documentation Specialist - Dublin

Description:

This position is responsible for actively participating in continuous improvement process mapping events and translating the output of those events into Standard Operating Procedures (SOP) and Work Instructions (WI). In this role, you should have excellent technical writing skills, relationship building and problem-solving skills. A high attention to detail and excellent verbal and written communications skills are vital to success in the role. High proficiency in MS word is essential.

Responsibilities:

  • Active participation in Continuous Improvement Projects
  • Writing and revision of Standard Operating Procedures (SOPs)
  • Track documents through approval process and work with approvers to deliver documents in line with Quality Control project plans
  • Provide training of revised/new procedures/processes to company 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 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/GDP standards
  • Strong problem-solving experience
  • Familiar with continuous improvement initiatives
  • Experience of SOP authoring and document management processes
  • 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

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.

Senior Internal Auditor - Clonmel

Description:

As a key member of the Regulatory Compliance team, ensure that the site is in compliance with applicable Corporate, FDA and International Regulatory requirements. Perform assessments of the company’s quality system to determine whether it is in compliance with the established requirements and to evaluate its effectiveness. Incumbent is responsible for the site Internal Audit Program. This role will require up to 50% travel across company sites globally.

Responsibilities:

  • Audits areas of the company’s quality system, as assigned.
  • Audits Commercial affiliate locations
  • Develops audit plans including scope and objectives. Creates audit checklists based on assigned area, applicable regulations, and pertinent company quality system/ procedural requirements, and obtains approval from RC Manager as appropriate.
  • Evaluates the adequacy and compliance of systems, operations, and practices against regulations and site documentation.
  • Documents identified non-conformities and obtains concurrence with responsible management.
  • Communicates final results of audits to responsible management internally and elevates to Division as needed.
  • Tracks issues through to closure including reviewing the corrective action taken.
  • Oversees follow-up of corrective actions and audit closure, including escalating overdue or at risk items as necessary.
  • Responsible for the site Internal Audit Program. Must adhere to the Divisional Internal Audit schedule and deliver high quality reports on time.
  • May serve as escort to inspectors or assessors from regulatory agencies or notified bodies.
  • Serves as Subject Matter Expert in company Quality System processes/procedures during internal/ external audits and to other business units as requested.
  • Conducts and documents Corrective and Preventive (CAPA) investigations for any audit findings in area of responsibility or as assigned.
  • Approves CAPA investigations in the system as required per procedure or as needed.
  • Supports site and Divisional Quality Systems projects as needed.
  • Develops and provides training on cGMPs and Quality System procedures as needed.
  • Supports Supplier Quality Engineering function by performing supplier audits as needed. Serves as Supplier Quality Engineer backup.

Minimum Qualifications and Experience:

  • National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline and 4+ years of related work experience.
  • A minimum of 8 years of related work experience in medical devices (preferably) or other FDA-regulated industry is required. Incumbent must have extensive experience on performing internal audits, managing external inspections/responses and be proficient in CAPA processes.
  • Strong understanding of specified area (Technical/Business Knowledge.)
  • Requires very strong leadership skills to positively influence others across departments and sites while conducting internal audits and defining/implementing required corrective/ preventive actions.
  • Incumbent must establish an extensive network of support in the site and across the Division to facilitate the completion of assignments. May participate in the development of less experienced staff providing guidance and offering counsel. May lead a project team. Should be able to influence management on technical and/or business solutions. May interact with suppliers.
  • Must be very organized and have strong planning skills to work on routine and non-routine tasks.
  • Ability to work on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercise judgement within generally defined practices and policies and selecting methods and techniques for obtaining solutions.
  • Ability to work in diverse cross-functional team environment.
  • Excellent written and verbal communication skills.
  • Detailed oriented.
  • Effective management of MS Office Applications – Word, Excel, Power Point.

Quality Assurance Specialist, Quality Control - Dublin

Description:

The QA Specialist for Quality Control will be responsible, with management support, for providing oversight of quality activities associated with the quality control processes at the manufacturing facility. The Specialist will contribute and guide completion of milestones associated with specific projects and support ongoing quality assurance responsibilities in support of but not limited to quality control processes at the manufacturing facility. The QA specialist will be required to support as required, packaging activities and quality systems including Change Control, Deviations and CAPA’s. Act independently to determine methods and procedures on new assignments and provide guidance to other personnel as required. Perform all responsibilities in accordance with company policies, procedures, and regulations.

Responsibilities:

  • Serve as Quality Assurance SME for quality control activities maintaining knowledge of industry standards and regulatory requirements to ensure all quality control activities are compliant.
  • Active member of the QA Operations team ensuring on-time disposition of finished product. This should be achieved through completion of the following activities:
  • Review and assess QC deviations; including performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending.
  • Review and assess QC Laboratory Investigations
  • Review and approve QC generated Corrective and Preventive Actions (CAPA); including tracking, follow-up, and reporting/trending and evaluating CAPAs for effectiveness.
  • Provide Quality support to QC department in method transfer or validation activities.
  • Support the work of the Quality Systems and Compliance team by the coordination and optimization of Quality Management Records relating to Deviation, Change controls and CAPA.
  • Support Global Complaints Handling Unit (GCHU) in complaint investigations.
  • Supports the business through coordination of day to day operations and change management relating to Quality e-Systems such as TrackWise
  • Generation, development and communication of Site Quality Metrics and measurements to support the on-going development of site compliance.
  • May create or revise standard operating procedures relating to various quality system elements
  • Represents Quality Assurance to guide various projects and technical meetings, as needed
  • Responsible for documenting and reporting compliance issues to management.

Minimum Qualifications and Experience:

  • Minimum of B.S. degree in Chemistry, Biology or related field
  • Minimum 3 years of experience in QA and/or QC.
  • Further technical training in the areas of problem solving, risk assessment would be an advantage
  • Thorough knowledge of cGMP/GLP/GDP and international regulatory requirements.
  • Demonstrated ability to coordinate and drive improvement in processes supporting Quality Systems or Quality Control.
  • Proven ability to identify, influence and drive process improvement.
  • English fluency written and spoken (the Company language). Efficient in SAP, firstdoc. and Trackwise® would be an advantage.

New Process Development Manager - Clonmel

Description:

New role to support the automation of drug spray and optimizing existing operations processes. Manage a team of 5 people to run a range of technical projects responsible for project delivery and budgetary requirements. Provides support to the manufacturing organization to facilitate efficient operations within the production area, to optimize existing processes, and to ensure that production goals are met. Monitors performance of equipment, machines and tools and corrects equipment problems or process parameters that produce non-conforming products, low yields or product quality issues. Interfaces with research and development organizations to integrate new products or processes into the existing manufacturing area. In addition to the above, this position will focus on automation of new and existing processes on site.

Responsibilities

  • New process development in automated drug coating to deliver significant cost reduction in the manufacturing process
  • Taking a lead role in development of project plan and execution of same from concept through to commercialization
  • Coordinating resourcing with multi-site stakeholders to meet project deadlines
  • Management, Leadership and motivation of a highly technical team of 5 to deliver on project goals’
  • Delivery of timely and accurate reporting on project delivery to senior leaders
  • Provide direction on preparation of key Process Documents, including Business Requirements Documents, Risks and Issues Logs and Project Plans
  • Managing relationships with internal customers throughout the life cycle of the project to ensure all business needs are met
  • Significant budgetary responsibility

Experience:

  • Technical/Business Knowledge (Job Skills)
  • 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 be performing 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 utilization 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 capable staff.
  • Provides leadership to assigned units by communicating and providing guidance towards achieving group objectives.
  • Planning/Organization
  • Schedules human and material resources within a group or section in conjunction with near-term plans to ensure their availability; carries out operations within an established budget.
  • Decision Making/Impact
  • Assignments are expressed 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 jeopardizing future business activity.
  • Supervision Received
  • Works under minimal supervision. Independently determines and develops approach to solutions.
  • Work is reviewed upon completion for adequacy in meeting objectives.
  • Supervision Provided
  • Provides direction and guidance to supervisors, ex 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.

Qualifications/Training:

  • Third level degree in Mechanical, Manufacturing, Production Engineering or similar discipline. A qualification in Project Management is an advantage.
  • Min 3 years experience in product / process development with Class II / III medical devices. Experience in Automation & Controls is an advantage but not essential
  • A proven ability to deliver highly visible and business critical projects on time and within budget.
  • Proven track record of success as a Project Manager coupled with strong relationship building skills, including written, face-to-face and remote (conference call/phone based).
  • Have a thorough and practical understanding of project lifecycles and the delivery of parallel cross-functional projects.
  • Demonstrated track record on project delivery
  • Ability to prioritize and to remain results orientated.
  • Strong analytical, verbal and written communications skills.
  • Strong technical competencies
  • Ability to effectively communicate to multi-function stakeholders at all levels of the organization

Automation Controls Engineer - Waterford City

Description:

The successful candidate would execute projects in a fast paced, multi-disciplined, cross- functional team environment

Responsibilities:

  • Develop and implement new technologies, controls and vision systems to improve cost and quality of existing strategic medical device products.
  • Facilitate internal resources and outside vendors in developing technical solutions for automated equipment. Interface with equipment vendors to ensure successful machine delivery, integration and manufacturing validation.
  • Develop specifications documents for new equipment and work closely with vendors to ensure the software related systems are correctly developed as per specifications.
  • Provide technical expertise in the validation of new technologies to ensure they meet the Safety, Quality and Operational requirements specified.
  • Develop and manage project schedules/detailed work plans in order to meet overall project goals. Communicate status of project activities on a regular basis.
  • Support product, platform and cost improvement programs by delivering qualified vision systems and acquisition software, machine controls and PLC/SCADA software. Interface with SQA, QA and Operations groups to successfully validate software systems. Author and execute software test scripts as required.
  • Identify improvement opportunities and provide business case analysis to quantify and justify automation projects.
  • Provide automation requirements and implement solutions for product lines and/or capacity expansions.
  • Provide technical and controls core competency support, including training to Operations and Engineering personnel on an as-needed basis, including possible off-hours, remote and onsite coverage rotation.
  • Travel to vendor locations for project reviews may be required.

Minimum Qualifications and Experience:

  • Degree in Electrical, Electro-Mechanical, Computer Systems or Electronic Engineering or other similar technology degree – or equivalent training/experience
  • Experience in high volume low cost manufacturing systems development desirable
  • Knowledge of software development life cycle methodologies, statistical analysis and machine vision fundamentals advantageous
  • Must be able to work with Operations staff, Manufacturing/Maintenance technicians and engineers in cross-functional team setting.
  • 5+ years’ experience with development, integration and project management of automated control systems including Vision systems, PLC’s, motion control, robotics, HMI’s and SCADA control systems software
  • Experience with equipment build, process automation, machine vision systems development and medical products advantageous.
  • Experience working in a cGMP/FDA regulated environment desirable

Fill Finish Validation Specialist - Dublin

Description:

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

Responsibilities:

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

Minimum Qualifications and Experience:

  • Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.
  • Minimum of five years’ experience in in fill-finish process development and/or manufacturing support with extensive practical knowledge of liquid fill operations.
  • Experienced in relevant unit operations including mixing, formulation, sterile filtration, sterilisation, aseptic processing, component processing technologies, liquid filling and visual inspection.
  • Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product drug manufacturing operations are cGMP compliant.
  • Experience of technology transfers and implementing new clinical and commercial biopharmaceutical manufacturing processes, specifically sterile liquid fill operations.
  • Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.
  • Familiarity with protein handling and processing considerations and how operating conditions can impact Critical Quality Attributes (CQA).
  • Experience of working with CMOs would be a distinct advantage, demonstrating strong communication and influencing skills.

Validation Engineer (Pharma) - Cork

Description:

The Validation Engineer is the technical owner and SME of the site Utility systems. Responsible for all quality and compliance issues, including deviation reporting and investigation, safety incidents, technical support and project support. Responsible for the HSE critical instrumentation, approval of all calibrations across the Technical Services department, and the Single Point of Contact (SPOC) for the site personal gas detector fleet. Responsible for ensuring that equipment is in compliance with all regulatory, statutory and client corporate requirements.

Responsibilities:

  • Day-to-day relationship with client engineering manager and team
  • Technical ownership of the site HVAC, and will ensure all HVAC systems are up to date with respect to GMP and FDA guidelines, as well as statutory and client corporate and local requirements
  • The Plant Compliance Engineer – is involved in Technical Service projects and issues (deviations, safety incidents etc.) across the site and potentially off site. This also includes trouble-shooting and high-level investigation of all related plant equipment faults and failures
  • The Plant Compliance Engineer – is responsible for numerous HSE critical instruments used to maintain the sites compliance with its Industrial Emissions Licence and will be required to discuss and defend these in front of auditors.
  • Responsibility for approval of all Technical Services calibrations on the computerised calibration system as well as being the SPOC for the site personal gas detector fleet.
  • Responsible for ensuring that all maintenance, preventative and unplanned, of assigned equipment/systems is completed on schedule, within budget, in a safe and satisfactory manner and all necessary documentation is completed.
  • Supporting site contract maintenance team in minimizing downtime and risk of downtime to facility
  • Updating of utilities related standard operating procedures
  • Identifying, liaising with, and, where appropriate, co-ordination of third party contractors and suppliers on site.
  • Liaising with site contract team to identify suppliers and quantities of spare parts; review and updating of spare part inventory of spares in clients site store.
  • Liaising with contract team and client to review maintenance programme, and effecting changes to methods and procedures where appropriate
  • Monitoring progress & quality of assigned tasks carried out by Projects, AIT and/or other departments.
  • Assisting client personnel with writing User Requirement Specifications for all systems under scope, and advising client representatives, where appropriate, of engineering requirements in User Requirement Specs for new equipment.
  • Identifying and implementing, where appropriate, energy saving schemes
  • Liaising with Quality and external auditing bodies upon audits.
  • Management of audit action items generated from various site, corporate, cGMP and EHS audits.
  • Ensuring Engineering areas, in liaison with Contract Manager and Contract co-ordinator, facilities and equipment are kept in a clean, safe and serviceable condition, and general housekeeping high standards are maintained.
  • Applying site standards and ensure standards are applied by others within the team.
  • Training of engineering and operation personnel on discipline related issues and assigned new or modified equipment/systems.
  • Contributing to process improvement/optimisation from an engineering viewpoint
  • Analysis of new technology for optimisation of plant and processes
  • Ensure that the maintenance standards adhere to the high cGMP and quality standards set on site.
  • Compliance with all Client & statutory standards
  • Ensure all SOPs and documents relating to maintenance are compliant.
  • Ensure all maintenance personnel are actively involved in Quality programs on site.

Minimum Qualifications and Experience:

Essential:

  • Engineering degree or equivalent, preferably mechanical/building services, with five years plus post graduate experience, or
  • Marine qualification or Trade qualification (National Craft Cert, City & Guilds or Equivalent), preferably mechanical/building services, with eight to ten years post apprenticeship experience.
  • A strong project management background and understanding of commissioning and qualification based on the ISPE Baseline Guide, Volume 5.
  • Maintenance and troubleshooting experience of the following systems and processes: HVAC; RO/Purified Water; Plant Steam; Clean Steam; LPHW and DH&CW Systems; Compressed Air; Process gases; Power distribution; Building Management Systems; Validation

Desirable:

  • Maintenance and troubleshooting experience of the following systems and processes – Waste water treatment, solvent recovery, incineration; pharma water and steam systems, fire suppression systems.
  • Design and/or modification of any/all of the above systems.

QC Chemist – Fill Finish – Waterford City

Purpose:

To support Product Development, Clinical Supply and launch of Parenteral Products. To Support Fill Finish Quality related tasks.

Responsibilities:

  • To draft/ review test methods.
  • To take part in laboratory and operation investigations 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.
  • To perform AQLs as required on Raw Material and Finished Products.
  • To perform inspection of Stability and Retention samples as required.
  • To support Fill Finish with Foreign matter investigations. (Identity, trending and Investigations)
  • Health and Safety
    • To ensure the requirements of EirGen’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
  • Strong analytical ability.
  • Strong quality orientation.
  • Good time management.
  • Strong attention to detail.
  • Good problem solving abilities.
  • Excellent organisational skills.
  • Ability to multitask and work under pressure, coping with more than one conflicting task at once.
  • Excellent communication skills, both verbal & written.
  • Adaptability – ability to maintain effectiveness in varying environments and with different tasks, responsibilities and people
  • Ability to work effectively with a team to accomplish organisational goals
  • Proficient in the use of electronic document management systems.
  • Proficient in Technical report writing
  • Strong Safety awareness.
  • Knowledge & proficiency of Microsoft products for example MS Excel, Word & Project, Power-point.

Quality Assurance - NPI - Waterford City

Description:

Reporting directly to the Quality Assurance Team Leader, as a critical leader for Sanofi, you will play an integral role within New Product Introduction and Analytical Services, transforming the support provided to these functions.

Responsibilities:

  • Acts as Quality Point person for systems / processes providing guidance / feedback on quality issues related to New Product Introduction
  • Working as part of the Quality Assurance team on site ensuring products are manufactured, stored and packaged in accordance with cGMP
  • 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

Minimum Qualifications and Experience:

  • Previous experience in NPI, in particular, the management and manufacture and release of IMPs
  • Provide ability to provide quality expertise & support to the QA team and site
  • Proven ability to support the delivery of projects across multiple platforms
  • Effective technical knowledge of sterile manufacturing processes
  • 5 years’ experience working in a Sterile manufacturing environment
  • 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
  • Good communication skills at organisation, team and individual levels
  • Understands KPI’s for the team and site

R&D Sterile Formulation Lead - Waterford City

Description:

To support the R&D department by providing significant fill-finish technical expertise to support all aspects of the formulation & manufacturing of sterile products. As a key member of the R&D team, your role is to provide leadership, cross-functional development and technical expertise on the aseptic manufacture sterile formulations

Responsibilities:

  • SME for sterile formulation of small molecule and biologic products
  • Apply a thorough knowledge of pharmaceutics to the development of drug products and the interpretation of in-vitro data to predict in-vivo performance.
  • Interpret in-vitro data for the purposes of further formulation development.
  • Provide scientific leadership across all the disciplines involved in Sterile Operations
  • SME for introduction of single use systems and assessment of their use in terms of extractables, leachables and container closure
  • Support all aspects of the manufacturing process from formulation development through to filling & lyophilisation
  • Technical review of change controls for impact to product quality, safety and efficacy
  • Provide on-floor technical support and troubleshooting
  • Identify and then lead process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing
  • Technical protocol and summary report generation as related to technical studies executed in direct support of GMP manufacturing activities
  • Collection, organisation, trending, and analysis of GMP manufacturing data
  • Identify manufacturing best practices across the network and lead or participate in teams to implement best practices
  • Ensure information transfer to Process Engineering group for all cycle development activities
  • Ensure appropriate scientific documentation is collated and approved for a robust Process Flow document
  • Ensuring that operational modifications or processing gaps are identified and updated in the operational control strategy
  • Lead technical feasibility review and technology gap analysis for new product introductions
  • Escalation of issues to the Sterile Technical Operations Manager, as appropriate
  • Communication of project data through presentations at internal meetings and through formulation development reports
  • Provide guidance and lead pivotal scale cGMP exhibit batch manufacture based upon a sound knowledge of site and departmental SOPs, and an understanding of ICH/FDA/EMEA requirements as they relate to formulation and process development activities
  • Maintain a comprehensive knowledge of formulations and process development disciplines through research and scientific literature

Technical Expertise:

  • Extensive operational experience within aseptic filling lines and formulations areas
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
  • Sterile filling processes and equipment
  • Pharmaceutical and Biotechnology formulation & manufacturing processes
  • Technical Primary pack knowledge and vendor knowledge (WEST, Schott, OMPI, etc.)
  • Demonstrable analytical and systematic problem solving skills

Skills/Qualifications:

  • Qualified to Honours Degree level in an appropriate science discipline
  • Minimum five years’ experience in relevant unit operations including mixing, formulation, sterile filtration, sterilisation, aseptic processing, component processing technologies, liquid filling and visual inspection
  • Significant exposure to sterile operations and/or Tech Transfer projects
  • Experience in fill-finish process development and/or manufacturing support with extensive practical knowledge of liquid fill operations
  • Comprehensive understanding of cGMP requirements for clinical and commercial manufacturing and the ability to implement best practices
  • Experience of technology transfers and implementing new clinical and commercial manufacturing processes, specifically sterile liquid fill operations
  • Familiarity with protein handling and processing considerations and how operating conditions can impact Critical Quality Attributes
  • Excellent knowledge of MS Office
  • Excellent knowledge of project management techniques and tools (e.g. MS Project)
  • Customer relations management (internal & external)
  • Multi-tasking, ability to manage conflicting deadlines
  • Excellent written, oral, interpersonal and presentation skills
  • Conflict management
  • Excellent computer skills to include MS office, ECDL certification an advantage
  • Proven time management skills
  • Planning & organizing
  • Project management
  • Knowledge of electronic document management system

Maintenance Technician – Arklow

Description:

Reporting to the Maintenance Manager, and working within a team based manufacturing facility, the successful candidate will be responsible for the maintenance and continuous improvement of automated and high-speed production, processing and packaging equipment pertaining to solid dosage manufacturing.

We are seeking candidates who share our core values of openness, hard work and respect to join our 20,000 plus worldwide team. A proactive and flexible approach is required.

Minimum Qualifications and Experience:

Candidates should ideally have completed a mechanical or electrical apprenticeship or equivalent and have experience of troubleshooting, repair, maintenance and improvement of electro-mechanical equipment in the pharmaceutical, chemical or food industries.

This is a shift based role.

Intermediate Molding Engineer - Clonmel

Description:

Provides support 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

  • Supports implementation and ongoing use of polymer-based injection molded components used in the manufacture of products
  • Supports molded commodities over lifecycle including product, process, quality and cost improvement initiatives, supplier and resin changes
  • Troubleshoot molding issues in conjunction with supplier and lead or 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 Modes and Effects Analysis (FMEA).
  • Identify critical dimensions and work with suppliers to ensure proper process controls are in place.
  • Participates in validation activity. Role may vary between providing input to owning activities such as protocol/report writing and managing execution of validation activities.
  • Interacts cross-functionally with internal and external customers and suppliers. Serves as a consultant for engineering or scientific interpretations and advice on significant matters.
  • Concurrent support of multiple projects.
  • Understands engineering principles, theories and concepts through to a wide range of complex and advanced problems which require novel and new innovative approaches or a breakthrough in technology.
  • Cultivates internal and external network of resources to complete tasks. May lead a project team, determining goals, objectives and managing schedules for the projects.

Qualifications:

  • Experience/Education
  • National Framework of Qualifications (NFQ) Level 7 qualification in a relevant discipline
  • 2+ years of relevant work experience or an equivalent combination of education and work experience.
  • Technical/Business Knowledge (Job Skills)
  • Working technical knowledge and application of principles, practices and procedures within the field of polymer component manufacture, in particular injection molding. General understanding of business unit functions and cross group dependencies/ relationships. Will perform this role within a quality system environment. Failure to adequately perform tasks can result in non-compliance with governmental regulations.
  • Cognitive skills
  • Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgement within defined procedures and practices to determine appropriate action. Must have a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.
  • Influence/Leadership
  • Cultivates a wide range of internal networks and begins to develop an external network of resources to facilitate completion of tasks. May lead a project team of moderate scope. Provides guidance to less experienced staff. Acts as a mentor to lower level individual contributors. Influence exerted at peer level and occasionally at first levels of management.
  • Planning/Organization
  • Plans, organises and prioritises own daily work routine to meet established schedule.
  • Decision making/Impact
  • Exercises authority and judgement within defined limits to determine appropriate action. Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources.
  • Supervision Received
  • Works under general supervision. Follows established procedures. Work is reviewed with soundness of technical judgement, overall adequacy and accuracy.
  • Supervision Provided
  • May provide limited 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.

Automation / Instrumentation Technician – Arklow

Description:

In this role you will be a member of the Maintenance team that provides day to day and project support within the automated production & packaging facility. You will be responsible for and involved in troubleshooting, maintenance and continuous improvement of the production processes and equipment. You will have the ability to understand Automation Systems and assess / diagnose PLC / PC programs and have a proven track record in solving automation problems to root cause using structured problem solving.

Responsibilities:

  • Experience of High Speed Vision systems (e.g Cognex, Keyence, Laetus etc.. )
  • Develop an in-depth knowledge of all control systems currently in use on site including PLC’s, motion systems, vision systems, electrical & safety systems and networks; While also helping develop a disaster recovery support program and system obsolescence program.
  • Operate as point of contact person for all automation related line down issues and projects.
  • Work closely with cross functional teams in monitoring equipment performance using proven troubleshooting and problem-solving techniques / methods to solve to root cause.
  • Support the continuous improvement of all automated equipment.
  • Ensure all new equipment and tasks are risk assessed, support investigation and near miss resolution, and proactively drive actions to reduce safety risks.
  • Support automation change control and manage software revision control systems in full compliance with business quality systems.
  • Carry out other relevant tasks as required by the Maintenance Manager / Designated Engineer.

Minimum Qualifications and Experience:

  • Senior Trade Qualification or Third Level Qualification in a relevant discipline
  • Experience of hands-on maintenance and troubleshooting of oral solid dose manufacturing equipment and high speed packaging equipment is desirable.
  • At least 2 years post-qualification experience
  • Electrical / Control System troubleshooting.
  • PLC / PC troubleshooting.
  • Pharma / Food experience desirable but not essential.
  • Proficiency in speaking, comprehending, reading and writing English is required
  • This is a shift based role

Technical Services Specialist (Process Engineer) - Athlone

Description:

The Technical Services Specialist has responsibility for providing technical support to clinical and commercial drug product manufacturing activities at the manufacturing facility. The successful candidate will be responsible for providing technical support through all phases of the product lifecycle, including technology transfer, process scale-up, process validation and routine commercial or clinical manufacturing. The position requires effective cross-functional working relationships with Manufacturing, Engineering, Facilities, Logistics, Quality Assurance and Quality Control groups which support day- to-day operations; interacting with Process Development and Analytical sciences for introduction of new products; and providing support for Regulatory submissions and inspections related to commercial and clinical products.

Responsibilities:

  • Provide significant fill-finish technical expertise to support all aspects of the manufacturing of commercial and future late stage clinical products at the Athlone Facility
  • Support technology transfers of new products into the Athlone Facility
  • Lead troubleshooting efforts and deviation investigations in conjunction with internal partners (Process Development, Manufacturing, and Quality etc.)
  • SME for introduction of single use systems and assessment of their use in terms of extractables, leachables and container closure.
  • Support all aspects of the manufacturing process from raw material selection and specification through formulation and filling to visual inspection, testing and release.
  • Technical review of change controls for impact to product quality, safety and efficacy.
  • Provide on-floor technical support and troubleshooting.
  • Identify and then lead process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing.
  • Technical protocol and summary report generation as related to technical studies executed in direct support of GMP manufacturing activities.
  • Collection, organisation, trending, and analysis of GMP manufacturing data.
  • Identify manufacturing best practices across the network and lead or participate in teams to implement best practices.
  • Support establishment of validation plans and evaluation of drug substance/product production site options
  • Provide SME input for IND, BLA and other technical documents for regulatory agency submission in support of manufacturing process operated in Athlone
  • Any other duties as required by management

Minimum Qualifications and Experience:

  • Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.
  • Experience in fill-finish process development and/or manufacturing support with extensive practical knowledge of liquid fill operations.
  • Experienced in relevant unit operations including mixing, formulation, sterile filtration, sterilisation, aseptic processing, component processing technologies, liquid filling and visual inspection. Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices
  • Experience of technology transfers and implementing new clinical and commercial biopharmaceutical manufacturing processes, specifically sterile liquid fill operations.
  • Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.
  • Familiarity with protein handling and processing considerations and how operating conditions can impact Critical Quality Attributes (CQA).

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.

Sterilisation Engineer - Clonmel

Description:

Provides technical support specific to terminal sterilisation activities to facilitate efficient operations, to optimise existing processes, and to ensure that production, quality and regulatory compliance goals are met. Interfaces with research and development and/or new product development to integrate new products or processes into the existing sterilisation processes

Responsibilities:

  • Initiates and completes technical activities leading to new or improved sterilisation processes to meet strategic goals and objectives of the company. Prepares reports and makes presentations to communicate findings
  • Incorporates business policies and procedures into task completion. Understands the business needs of the company, and has a thorough knowledge of the customer and clinical needs of our business. Understands the business cycle and foresight of emerging technologies trends
  • Understands the regulatory requirements pertaining to the job and ensures sterilisation processes meet them
  • Cultivates internal and external network of resources to complete tasks. Serves as a resource in the selection orientation and training of new engineers and employees. May lead a project team, determining goals and objectives for the projects. Mentors employees by sharing technical expertise and providing feedback and guidance
  • Interacts cross functionally and with internal and external customers, in particular, developing good relations with contract sterilisation facilities
  • Ensure there is sufficient backup capacity in place for sterilisation processes

Minimum Qualifications and Experience:

  • Experience/Education
  • National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline
  • 2+ years of related work experience or an equivalent combination of education and work experience
  • Technical/Business Knowledge (Job Skills)
  • Wide application of technical principles, practices and procedures.
  • Strong understanding of business unit functions and cross group dependencies/ relationships.
  • Will perform this job in a quality system environment. Failure to adequately perform tasks can result in non-compliance with governmental regulations.
  • Cognitive Skills
  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
  • Exercises judgement 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.
  • May interact with vendors.
  • Planning/Organisation
  • Plans and organises non-routine tasks with approval.
  • Initiates or maintains work schedule.
  • Establishes priorities of work assignments.
  • Decision Making/Impact
  • 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.
  • 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.

QA Validation Specialist - Dublin

Responsibilities:

  • Provide quality and cGMP input and oversight for all start-up project activities through commercial readiness and ongoing product disposition.
  • Provide QA support for risk based verification activities in the capacity of Quality Assurance Subject Matter Expert. Review and approval equipment/utilities verification documentation from design to post execution.
  • Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled.
  • QA support for implementation of Manufacturing Execution System (MES) computer system validation deliverables.
  • Review and approval of engineering functional area documentation (SOP, Work Instructions, Criticality Assessments, technical report and protocols).
  • Authoring, review and approval of QA-related procedures.
  • Oversee the effective documentation and tracking of quality management system activities including deviations and change controls and CAPA.
  • Review and approve Validation protocols as required. (Examples include cleaning, process, method validation).
  • Support the vendor quality management programme.
  • Participate in regulatory inspections as required.
  • Develop and report quality metrics.
  • Provide quality oversight of calibration and preventative maintenance criticality assessments as required.
  • Represents Quality Assurance to guide various projects and technical meetings, as needed.
  • Responsible for documenting and reporting compliance issues to management.
  • Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.

Minimum Qualifications and Experience:

  • B.Sc. in science/pharmacy with a minimum of 5 years’ experience in cGMP Quality environment to include biopharmaceutical experience.
  • Min 5 years QA experience in a pharmaceutical manufacture/biopharmaceutical environment. (BDS experience is essential).
  • Must have strong process knowledge to include upstream and/or downstream processing.
  • An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
  • Excellent communication & presentation skills are essential.
  • Excellent time management organizational skills along with a proven ability to multi-task.
  • Knowledge of automation and IT systems a distinct advantage.

Formulation Scientist – Waterford City

Responsibilities:

  • Project Planning:
    • Together with the Formulation Development Manager and Formulation Development Team Lead, actively plan on-going formulation development requirements; ensuring major milestone targets for each project are visible to all team members and key stakeholders to achieve on time market entry.
    • Together with the Formulation Development Manager and Formulation Development Team Lead, determine tasks required to deliver each project milestone by breaking them down into tasks; identify equipment, materials and people needed.
    • Proactively build effective working relationships with Core Team and Functional Members.
  • Compliance:
    • To ensure that work carried out is in compliance with required standards conforming to company, cGxP, SOPs, regulatory regulations & guidelines, Health, safety and environmental guidelines.
    • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement. Highlight opportunities for system optimisation to team members.
    • To support all on-going formulation and regulatory functions & requirements.
    • To complete all documentation correctly in order to achieve a high level of customer satisfaction and compliance to GMP.
    • To prepare reports and submission documentation in support of licence applications to various regulatory authorities.
    • To perform additional team tasks as agreed to support effective running of the Business
  • Health & Safety
    • Ensure requirements of company Safety Statement are implemented
    • Continuously promote a positive safety culture by leading by example
    • Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs
    • Report any defects

Minimum Qualifications and Experience:

    • Qualified to a minimum of honours degree level in Pharmaceutical science or related discipline.
    • At least five years’ experience working in a formulation development, process development, manufacturing or related technical environment.
    • Pre-formulation experience, including drug characterisation and ingredients selection.
    • Formulation studies, considering such factors as particle size, polymorphism, pH and solubility, as all can influence bioavailability and drug activity.
    • Process optimisation and scale up experience are essential
    • Analytical/ laboratory experience would be advantageous.
    • Have demonstrated effective research skills, including the critical review of the scientific literature.
    • Knowledge of all drug product manufacturing processes is essential.
    • Fill Finish and Dry Powder Inhalation (DPI) experience is advantageous.

QC Chemist – Waterford City

Description:

Contribute to the continued success of our client’s QC department by providing analytical services to support our diverse manufacturing operations. Engage with their Continuous Improvement programme to share your ideas and experience to further optimise the laboratory function. Comply with all regulatory and safety guidelines to protect yourself, your colleagues and patients.

Responsibilities:

  • Provide analytical chemistry services and support to Site
  • Effective interaction with other departments on matters related to raw materials, intermediates and finished batch releases. In particular, close contact maintained with Quality Assurance Production, Engineering and Planners
  • Maintain, update and issue chemical methods, specifications and SOP’s in compliance to pharmacopoeial and regulatory requirements
  • Assist with training of the analysts in areas of expertise and knowledge and in new methods, SOP’s and updates
  • Trend such results, record on COA’s where required and complete OOS’s investigations on a timely basis
  • Support new product introduction projects

Skills/Qualifications:

  • Degree in Science (Chemistry or Biochemistry preferred). Post-graduate studies as appropriate to augment primary degree
  • Operational experience of quality laboratories in a fast moving manufacturing environment
  • Detailed knowledge of quality management systems, pharmaceutical manufacturing operations, requirements for cGLP, pharmacopoeial methods and stability
  • Understand relevant quality/compliance regulations
  • Can manage projects to plan/budget

Chemistry Analyst Level 3 - Waterford

Description:

The purpose of this job is to review scientific test procedures used on client samples ensuring that accurate results have been produced. This person will also work to develop any ancillary procedures associated with the processes used; ensuring customer samples are completed within their required specifications.

Responsibilities:

  • Responsible for reviewing data to the relevant regulatory standard, analytical procedures and appropriate documentation.
  • Responsible for the review of specific technological projects and writing up the results of these projects accurately, confidentially and on time for the clients.
  • Data Reviewers are permitted to sign all technical documents within the company once their training in this task is successfully completed. This includes laboratory reports, SOPs, protocols, investigation reports and any other documentation issued.
  • This person will perform analytical testing when not engaged in Data Review activities.
  • This person will ensure that all documentation is completed on time, accurately and legibly.
  • Responsible for updating any relevant documentation as required.
  • Responsible for handling any customer related queries where necessary and liaising with their team to problem solve these queries if needed.
  • To keep their training records up to date and to initiate training as per their training plan where possible when free from work
  • To adhere to all company standards in the area of safety, housekeeping and quality, notifying management of any discrepancies.
  • To ensure that customers’ requirements are fully met and in so doing be flexible to work in any area of the business as is required.
  • To identify any opportunities for improvement of quality and service and work with the team to implement continuous improvement.

Skills/Qualifications:

  • A degree or diploma in chemistry or a related discipline is desirable
  • At least 28 months experience in a GMP laboratory
  • Good team player, organised, accurate, have strong documentation skills
  • Passionate about quality and customer service
  • Good communication skills both internally and externally

QA Officer – Waterford City

Purpose:

The main purpose of the role is to support manufacturing areas with QA support including but not limited to the following:

  1. Real time in situ batch documentation review

  2. Real time assessment of manufacturing events from a QA perspective.

  3. Provide clearance to precede instructions in manufacturing following unplanned events. 

Minimum Qualifications and Experience:

  • A third level degree incorporating Quality Assurance/ Management.
  • Have minimum 2 years relevant experience in a Pharma role / GMP related role.
  • Experience with desktop and internet-based software applications (e.g. electronic document management system, MRP system) an advantage but not essential.
  • Excellent communication and presentation skills
  • Focus on quality and detail
  • Careful planning to achieve accurate and timely result
  • Ability to define and manage own tasks and schedules
  • Experience performing and assessing risk/impact assessment an advantage

Senior Infrastructure Engineer - Waterford City

Description:

The Senior IT Infrastructure Engineer will support the Infrastructure/DBA Lead for all site IT Infrastructure, including Servers, PCs, Data Storage, Network infrastructure, security, business continuity and applications.

Responsibilities:

  • Responsible, as part of a team, for providing support to a very large number computing devices and users within the Waterford Facility
  • Will be required to provide out of hours support on a Rota basis to the Plant for critical areas – Minimizing Downtime.
  • Expert in enterprise systems and software such as SCCM, GPO, AD, DNS, DHCP, Bitlocker etc
  • Proficiency in system admin scripting
  • Capable of design, configure and support of computer Infrastructure including Network, SAN, NAS, Servers, PCs, Laptops, Centralized Print System and general hardware
  • In-depth knowledge of windows patching and WSUS
  • In-depth knowledge of backup systems such as Data Protector and Veeam
  • Responsibility for Backup, Restore and Disaster Recovery strategies.
  • Responsibility for VMWare solution – configuration & support.
  • Responsibility for various Infrastructure projects.
  • Responsibility for Computer & Comms rooms – fiber, cabling, power, cooling & general facilities
  • Good understanding of cisco switches and access points
  • Installation and support of various software applications.
  • Liaise with vendors on technical projects, installations and error resolution
  • Knowledge of enterprise systems such as Office365, desktop backups, web proxy, firewall
  • In-depth knowledge of mobile devices such as phones and tablets
  • In-depth knowledge of server storage solutions
  • Be able to juggle a mix of 70% daily tasks and 30% infrastructure projects
  • Familiarity with administering oracle databases advantageous

Skills/Qualifications:

  • Third level Qualification in Computer Science or similar
  • Professional Project Management Certified is preferred
  • 3 years experience in a similar role
  • Previous experience in regulated manufacturing environment advantageous
  • Familiarity with administering oracle databases is desirable

QA Operations Specialist – New Product Introduction – Dublin

Responsibilities:

  • Provide quality and cGMP input and oversight focused on the transfer of new products to the site – through commercial readiness and ongoing product disposition for biologics facility.
  • Provide QA support for risk-based verification activities in the capacity of Quality Assurance Subject Matter Expert.
  • Support the introduction of all associated new materials, including qualification of the materials and associated vendors.
  • Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained / controlled.
  • Review and approval of technical support documentation. (Examples include associated technical transfer documentation, process, method validation)
  • Review and approval of manufacturing batch records.
  • Review and approval of functional area documentation (SOP, Work Instructions, Criticality Assessments, technical report and protocols.)
  • Provide quality support for implementation of new product on SAP.
  • Authoring, review and approval of QA-related procedures.
  • Oversee the effective documentation and tracking of quality management system activities including deviations and change controls, CAPA, and batch disposition.
  • Review and approve Validation protocols and reports as required.
  • Support the vendor quality management programme.
  • Participate in regulatory inspections as required.
  • Represents Quality Assurance to guide various projects and technical meetings, as needed.
  • Responsible for documenting and reporting compliance issues to management.
  • Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.

Skills/Qualifications:

  • B.Sc. in science/pharmacy/engineering with a minimum of 5 years’ experience in cGMP Quality environment
  • Min 5 years QA experience in a pharmaceutical manufacture/biopharmaceutical environment. (BDS experience is an advantage).
  • Should have strong process knowledge to include upstream and/or downstream processing.
  • An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
  • Excellent communication & presentation skills are essential.
  • Excellent time management organizational skills along with a proven ability to multi-task.

Principal Scientist - Lyophilisation - Waterford City

Purpose:

The role is to support the the design and scale-up of lyophilisation processes suitable for clinical production, including cycle optimization, robustness studies, and technology transfer.  Candidates should have biotechnology educational attainments, a minimum of five years’ experience within the pharmaceutical industry, preferably in a Biopharma role with significant exposure to Lyophilisation & cycle development, and have ideally worked within an aseptic fill finish environment.  

Responsibilities

  • Advise on lyophilisation cycle development, optimization, scale up and Technology Transfer of finished products using state of the art techniques
  • Design and execute accelerated stability testing plans that demonstrate suitability of Lyophilised formulations
  • Complete required batch documentation records with accuracy and legibility
  • Ensure product quality by performing in-process checks, complying with current good manufacturing practices
  • Track and report deviations to a process, initiating quality improvements and participating on quality improvement projects as required.
  • Act as R&D liaison between relevant Managers, Q A, Research, Tech Services, Engineers and Maintenance personnel in all matters regarding freeze drying
  • Participate on manufacturing project teams to assist with cycle development through collaboration with R&D.
  • Review work scope, rationale, approvals, changes to appropriate equipment/systems and re-qualification activities
  • Assist in the training of sterile operators or cross-training in other areas.
  • Troubleshoot and perform adjustments on equipment as required.
  • Ensure that all work is carried out in compliance with the required standards to conform to company, cGxP, health and safety, environmental and regulatory requirements.

Qualifications:

  • You MUST be passionate about Lyophilisation and Biopharma
  • An honours degree in Science/Biotechnology (or a related discipline)
  • You MUST have at least 5+ years’ experience
  • Significant exposure to Lyophilisation & cycle development
  • Ideally have worked within an aseptic fill finish environment
  • Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations.

Project Engineer – Waterford City

Description:

Executes and delivers key strategic projects, which increase the capability and capacity of our client. Applies engineering skills applicable to medical devices manufacturing, for all aspects of project delivery from feasibility, through manufacturing start up and hand over to the operations team. Aligns the requirements of other functional groups such as EHS, QA, Manufacturing, Engineering, Supply Chain, Facilities/Maintenance, and Validation for an overall project delivery. Directly responsible for tracking project cost, schedule, targets and achievements.

Responsibilities:

  • Manage multiple small to medium medical device projects from concept through design for manufacture, commissioning and qualification.
  • Assist Supply chain in identification of suppliers and sub-contractors.
  • Apply sound engineering and project management principles, in the delivery of the project.
  • Interface with client representatives, and other functional groups such as EHS, QA, Manufacturing, Engineering, Supply Chain, Facilities/Maintenance, and Validation etc., to manage and coordinate the development of project deliverables.
  • Generate project plans, scopes of work, cost estimates and quotations.
  • Generate work instructions and action change notes.
  • Manage internal / external teams to meet project schedules.
  • Review and approve documentation including specifications and drawings.
  • Manage manufacturing, assembly, tooling/fixture design and commissioning & validation activities.
  • Review and/or approve commissioning and qualification protocols.
  • Provide qualification and troubleshooting support for equipment and processes.
  • Independently manage technical, engineering and compliance matters relating to the projections on engineering problems and methods.

Skills/Qualifications:

  • Minimum 3 years of relevant experience within a medical devices environment, will also
  • consider other similar regulated industries such as pharmaceuticals.
  • Minimum of Bachelors’ degree (Honors) in Engineering (Level 8) – 2:1 Minimum
  • Proficient in Oral & Written communication skills
  • Must be able to read, write and understand English
  • Proficient in MS Excel & MS Project
  • Commissioning & Validation Experience – Equipment & Process experience preferred
  • Proficiency in a CAD package such as Solid Works, or equivalent, preferred
  • Proficiency in a Statistical Analysis package such as Minitab, or equivalent, preferred
  • Proficiency in an MRP package such as SAP, preferred
  • Ability to work on own initiative and to challenging schedules
  • Organized and adaptable with a flexible approach to Project Engineering

Quality Assurance Specialist – Sterile Operations – Waterford City

Description:

Reporting directly to the Quality Assurance Team Leader, as a critical leader for our client, you will play an integral role within the Sterile Operations area, transforming the support provided to these functions.

Responsibilities:

  • Acts as Quality Point person for systems / processes providing guidance / feedback on quality issues related to Sterile Manufacturing activities
  • Working as part of the Quality Assurance team on site ensuring products are manufactured, stored and packaged in accordance with cGMP
  • 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

Skills/Qualifications:

  • Previous experience in sterile operations in particular the management and manufacture and release of sterile product
  • Provide ability to provide quality expertise & support to the QA team and site
  • Proven ability to support the delivery of tasks in a highly regulated manufacturing environment
  • Effective technical knowledge of sterile manufacturing processes
  • Minimum 5 years’ experience working in a Sterile manufacturing environment
  • 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
  • Good communication skills at organisation, team and individual levels
  • Understands KPI’s for the team and site

BDS Manufacturing Technologist - Dublin

Responsibilities:

  • Manufacturing Technologists are responsible for Manufacturing Support to the BDS operations at College Park, 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 College Park 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 client 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

QA Operations Specialist (NPI) – Dublin

Responsibilities:

  • Provide quality and cGMP input and oversight focused on the transfer of new products to the site – through commercial readiness and ongoing product disposition for biologics facility.
  • Provide QA support for risk based verification activities in the capacity of Quality Assurance Subject Matter Expert.
  • Support the introduction of all associated new materials, including qualification of the materials and associated vendors.
  • Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained / controlled.
  • Review and approval of technical support documentation. (Examples include associated technical transfer documentation, process, method validation)
  • Review and approval of manufacturing batch records.
  • Review and approval of functional area documentation (SOP, Work Instructions, Criticality Assessments, technical report and protocols).
  • Provide quality support for implementation of new product on SAP.
  • Authoring, review and approval of QA-related procedures.
  • Oversee the effective documentation and tracking of quality management system activities including deviations and change controls, CAPA, and batch disposition.
  • Review and approve Validation protocols and reports as required.
  • Support the vendor quality management programme.
  • Participate in regulatory inspections as required.
  • Represents Quality Assurance to guide various projects and technical meetings, as needed.
  • Responsible for documenting and reporting compliance issues to management.
  • Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.

Minimum Qualifications and Experience:

  • B.Sc. in science/pharmacy/engineering with a minimum of 5 years’ experience in cGMP Quality environment
  • Min 5 years QA experience in a pharmaceutical manufacture/biopharmaceutical environment. (BDS experience is an advantage).
  • Should have strong process knowledge to include upstream and/or downstream processing.
  • An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
  • Excellent communication & presentation skills are essential.
  • Excellent time management organizational skills along with a proven ability to multi-task.

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

Senior Quality Systems Engineer (MDR Implementation) – Waterford City

Description:

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 lens manufacturing plant. This role will report to the Quality Systems Manager.

Responsibilities:

  • Assist with the execution of Medical Device Regulation in the manufacturing plant as identified by the MDR Project team
  • Implement any Plant Quality systems changes as identified by the MDR Project team
  • Implement plant Change management activities for the implementation of MDR QMS

Requirements

  • Provide Supplier Quality support to any supplier changes / material changes that will occur due to MDR
  • Support new MDR Requirements around post market Surveillance
  • Work closely with the plant ensuring clear communication of any new MDR requirements
  • Support risk management, risk analysis and health hazard analysis associated with post market information.
  • Additional requirements of the job will be specified by the Quality Systems Manager

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

Senior Quality Officer – Waterford City

Description:

The Senior QA Officer will manage and co-ordinate Quality Assurance activities and resources associated with the Pharmaceutical manufacturing and release of Products. They will be responsible for facility compliance with regulatory commitments, in-house requirements and cGMPs.

Responsibilities:

  • Responsible for facility compliance with regulatory commitments, in-house requirements and GMP
  • Preparation of procedures and policies for area of responsibility
  • Responsibility for maintenance and development of GMP awareness facility-wide, including: preparation and execution of training programmes, assessment of GMP training requirements, and execution of internal GMP auditing
  • Investigation for QA review of all GMP critical documents and documentary review
  • Participate and manage in the introduction and maintenance of Global Quality Management Systems (GQMS)
  • In-house auditing and line clearance procedures
  • Exception and deviation management e.g. deviations, Alarms, OOS, etc
  • Support quality aspects of materials management including supplier approval, supplier complaints and specification management
  • Provision of support and assistance in execution and control of validation programmes

Regulatory Activities:

  • Maintenance of site master file
  • Preparation of annual reports and activities i.e. Product Quality Review, Mock Recall etc
  • Trending of complaints
  • Maintain manufacturing licence, variations etc

General and Environmental Standard Operating Procedures:

  • Participate in team based project work and plant-wide initiatives to improve the GMP compliance and financial performance of the Envision area
  • Other duties as assigned supervision management

Key eGMP Responsibilities:

  • Maintain, develop and manage QA systems
  • Follow Standard Operating Procedures while carrying out duties at all times
  • Participate fully in all GMP and operational programs and complete all Training Records in an accurate and timely manner

Minimum Qualifications and Experience:

  • Third level Qualification in Science
  • Minimum 3-5 years’ experience in a regulated pharmaceutical with at least 2 years in a senior Quality Role preferable
  • Full understanding and experience of the requirements of Pharmaceutical Regulations, CGMP Guidelines, ISO 13485
  • Must have ability to analyze and provide Quality Direction on product / equipment issues using independent judgement
  • Must be self-motivated, with ability to work on own initiative and prioritize
  • Must have experience of team working and excellent communication skills
  • High attention to detail

Project Co-Ordinator (Senior Engineer) – Waterford City

Description:

This engineer will lead product development & process development activities, writing protocols, data gathering and analysis. The Candidate will be skilled in reporting and presentation of data analysis. Candidates will lead data analysis and provide recommendations on trends, correlation, response variables, DOE’s etc. in an effort to better understand process interdependencies. The candidate will co-ordinate requirement setting to define automation requirements. They will also lead process capability finalization for manufacturing and conduct complete transfer of mature processed to manufacturing. The candidate will be interfacing with and leading internal cross functional teams while working on the programs.

Responsibilities:

  • Lead new produce/process validation
  • Design, execute and analyze experiments. Teach others to use analytical analysis tools and drive data driven decision making
  • Lead process optimization
  • Develop and support new manufacturing processes and technologies
  • Lead existing manufacturing processes, quality improvements and cost reductions
  • Ensure product quality and all tasks are in accordance with established SOPs, GMPs,
  • Divisional Specifications and EHS standards
  • Train manufacturing and junior personnel

Minimum Qualifications and Experience:

  • Degree in Scientific or Engineering Discipline
  • Special Skills: Computer Literacy with skills in Microsoft Excel, Word and PowerPoint, plus Minitab, JMP (or equivalent software)
  • Expertise in Statistical Analysis including experience of DOE and SPC. Communication, organization, report writing and presentation skills a must
  • Must be able to develop working relationships with various internal core Competencies and lead team members
  • Specialized Training: Six Sigma Black Belt and DFSS experience preferred
  • Minitab/JMP Statistical Software preferred
  • 5 years experience in a similar industry

Instrumentation Specialist – Waterford City

Description:

To provide specialised technical support to the analytical functions to support all on-going Development, QC and Stability functions. This includes, but is not limited to, the following areas:

• Equipment Maintenance

• Calibration

• Laboratory Computerised Systems

Responsibilities:

• To perform instrument calibrations including balance monthly calibrations, HPLC, UV, FT-IR, Conductivity Meter and Dissolution baths etc.

• To organise and sign off on external PM and calibrations.

• To maintain equipment calibration and maintenance schedules.

• To perform Instrument and method trouble shooting as required.

• Attends meetings within the company to discuss changes and modifications in laboratory equipment.

• To ensure that all work carried out is in compliance with the required standards, conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental 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 effective running of the Business.

Health and Safety

  • To perform Safety Tasks – New Material Assessment Risk Assessments etc
  • Implement Safety requirements as per site documentation including SOPs, Safety Statement and COPs
  • Reports any Defects
  • If Unsure about safety requirements – ask

Minimum Qualifications and Experience:

  • Qualified to a minimum of degree level
  • At least five years’ experience working in a related technical environment is preferable but not essential
  • Troubleshooting of Analytical Equipment
  • Operation of HPLC, UV, FT-IR, Dissolution Bath etc.
  • Knowledge of laboratory computerised systems e.g. Empower
  • Computer skills and Project Management