Senior QC Specialist -Equipment & Instrumentation Hybrid RK5368 Contract 12 months Dublin Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. This role is responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities and for ensuring that all maintenance & calibration activities carried out by Calibration Technicians are tracked & managed through the Computerised Maintenance Management System (CMMS) Maximo. Duties: Planning and conducting routine calibration, requalification and maintenance of laboratory equipment ensuring calibration and maintenance schedules are adhered to as per CMMS Maximo. Reviewing & filing of QC calibration & maintenance documentation. Planning, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment, including the writing of equipment validation protocols and associated summary reports. Conduct periodic reviews of instrument validation as part of validation life cycle. Alerting Quality Control Management in the event of equipment failing to meet calibration or qualification requirements and conducting impact assessments/investigations as required. Scheduling and coordination of equipment repairs and maintenance with vendors/contractors, while minimizing level of down-time for lab equipment, and disruption to laboratory activities. Participation in technical project teams to act as a subject matter expert on instrument validation regulations and procedures. Where applicable, owns and project manages change controls and adherence to Change Control metrics Supporting and managing the addition of project components to CMMA Maximo Act as a key contributor and sponsor to Data Integrity Assessments for Lab systems Any other tasks/projects assigned as per mangers request Educational and Experience Bachelors degree in a Science related field is required. Minimum of 3 years of laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation and data integrity assessments. Hands-on laboratory equipment lifecycle and validation experience Detailed knowledge of the methodology, and instrumentation and analytical techniques used for biopharmaceutical testing. Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity. Demonstrated success in managing an equipment qualification or maintenance program advantageous. If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information. TPBN1_IJ
Senior QC Associate -Equipment & Instrumentation Hybrid RK5367 Contract 12 months Dublin Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. This role is responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities and for ensuring that all maintenance & calibration activities carried out by Calibration Technicians are tracked & managed through the Computerised Maintenance Management System (CMMS) Maximo. Duties: Planning and conducting routine calibration, requalification and maintenance of laboratory equipment ensuring calibration and maintenance schedules are adhered to as per CMMS Maximo. Reviewing & filing of QC calibration & maintenance documentation. Planning, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment, including the writing of equipment validation protocols and associated summary reports. Conduct periodic reviews of instrument validation as part of validation life cycle. Alerting Quality Control Management in the event of equipment failing to meet calibration or qualification requirements and conducting impact assessments/investigations as required. Scheduling and coordination of equipment repairs and maintenance with vendors/contractors, while minimizing level of down-time for lab equipment, and disruption to laboratory activities. Participation in technical project teams to act as a subject matter expert on instrument validation regulations and procedures. Where applicable, owns and project manages change controls and adherence to Change Control metrics Supporting and managing the addition of project components to CMMA Maximo Act as a key contributor and sponsor to Data Integrity Assessments for Lab systems Any other tasks/projects assigned as per mangers request Educational and Experience Bachelors degree in a Science related field is required. Minimum of 3 years of laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation and data integrity assessments. Hands-on laboratory equipment lifecycle and validation experience Detailed knowledge of the methodology, and instrumentation and analytical techniques used for biopharmaceutical testing. Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity. Demonstrated success in managing an equipment qualification or maintenance program advantageous. If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information. TPBN1_IJ
Associate Quality Specialist Onsite RK26071 Contract 11 months Tipperary Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Tipperary. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Key Responsibilities: Participate as functional expert in the cross functional team that manages production right first time. Review and approve batch, cleaning and testing documentation. Ensure that all Laboratory Out of Specification (OOS) and process deviations are documented, assessed and associated CAPA identified. Provide support to deviation investigations and process performance monitoring. Perform trending on deviations raised as required to identify improvement initiatives. Provide detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed. Provide guidance on quality requirements to maintain validation status, including participation in process/product Risk Assessments. Provide feedback on re-occurring issues ensuring continuous improvement to systems/processes. Ensure changes controls raised are documented, assessed and completed. Prepare Annual Process and System Reviews. Act as lead/team auditor to support the internal GMP walkdown and scheduled audits. Participate in the generation and communication of quality metrics. Creation, review and approval of quality procedures as required. Education and Experience: Degree or post-graduate qualification in Science, Pharmacy or equivalent. Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise). Spray drying experience desirable. Knowledge and demonstrated expertise in Lean / Continuous Improvement. Experience and knowledge of GMP Requirements for Electronic /paper free operations. Experience in High potency manufacturing desirable. If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information. TPBN1_IJ
Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Ideally the person will be responsible for one or more of the following activities in QC including microbiological testing, method transfers, sample and data management and equipment maintenance. This role is for an experienced and technically strong associate who will spend 90% of their work day performing testing. Responsible for: Environmental Monitoring of Grade 8/9 Cleanrooms Environmental Monitoring of Grade 5/7 Cleanrooms & Isolators Reading of Environmental Monitoring Plates Bioburden testing of water & disinfectants Writing technical reports Water sampling Testing of In Process samples such as Density & pH Technically strong background in microbiology and aseptic manufacturing Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage Flexibility the EM role often encounters changing priorities on a daily basis Problem solving skills Experience with Regulatory inspectors and interacting with inspectors desirable Demonstrated ability to work independently and deliver right first time results Works under minimal direction Work is guided by objectives of the department or assignment Follows procedures Refers to technical standards, principles, theories and precedents as needed May set project timeframes and priorities based on project objectives and ongoing assignments. Recognizes and escalates problems Demonstrated leadership and communication skills Auditing documentation and operation process Demonstrated ability to interact with regulatory agencies Education and Skills: Bachelors degree in a science discipline?with 3+ years of experience in the pharma or biopharma industry. Biopharmaceutical QC experience in a microbiology lab? Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products Experience working in an aseptic cleanroom performing Environmental Monitoring Proficient in the use of LIMS & LMES If interested in this posting please feel free to contact Avishek Singh at avishek.singfor further information. TPBN1_IJ
Material Controller (Biopharma) Cork Full-Time | Onsite Our client is seeking to hire a Material Controller to join their team in Ringaskiddy, Cork on a full-time basis. You will be based in a laboratory-related environment, supporting scientific processes and ensuring smooth material flow to meet customer business needs. This opportunity is ideal for someone coming from retail, warehouse, or hospitality environments who would like to join a leading company with excellent opportunities for progression. We welcome applicants from all industries, as full training will be provided. Education/Experience: Education: Leaving Certificate completion or equivalent; Bachelors degree preferred Experience: Consistent work history in areas such as warehouse, inventory, retail, hospitality, or similar Additional Skills: Positive attitude, strong work ethic, and familiarity with general warehousing terminology and practices IT Skills: Good knowledge of Microsoft Word, Excel, and Outlook required Role/Responsibilities: Handle and manage stock in compliance with GMP processes Maintain accurate inventory records and ensure timely stock replenishment Support laboratory operations by managing material flow and ensuring correct stock levels Process ad-hoc material requests and coordinate with suppliers as needed Operate equipment and follow all site and regulatory requirements Perform routine administrative tasks related to stock control and compliance Who You Are Detail-oriented and proactive Comfortable working in a customer-focused environment Thrive in a fast-paced setting and enjoy taking ownership of tasks Whats on offer: 37,5 hours per week, only one shift, no weekend work Private health care Bonus system 25 days holidays Pension scheme Employee Assistance Program For further information please contact: Karen Shiel on or send CV to Skills: Inventory Management Stock Control Customer Service TPBN1_IJ
Quality Assurance Specialist Shift RK26065 Contract 11 months Carlow Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Key Responsibilities: Provide Quality support to IPT production teams to ensure cGMP standards are maintained. Understanding of sterile manufacturing operations is preferred. Ability to learn and utilize computerized systems for daily performance of tasks. Ability to prioritize, manage multiple tasks, and meet deadlines. Perform timely reviews on batch documentation ( EBRs ) / line clearances/ assist in the resolution of concerns commensurate with the risk. Liaise with other Department representatives to promote improvements in GMP and Quality standards Comply with our current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations. Education and Experience: Bachelors Degree or higher preferred in a Science discipline 1-2 years experience in a Quality Role at pharmaceutical manufacturing facility preferably aseptic manufacturing Experience in SAP, MES, Trackwise desirable Working knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information. TPBN1_IJ
Senior Quality Assurance Associate Shift RK5335 Contract 12 months Dublin Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. This role plays a pivotal role in the site's Quality Assurance team. As the Quality point of contact for manufacturing and inspection operations, the PQA Senior Associate will contribute to continuous improvement initiatives by undertaking additional responsibilities beyond routine QA duties. This 24/7 shift role demands a 12-hour shift pattern (4 on, 4 off) to support manufacturing operations. Key Responsibilities: Ensure adherence to safety standards and SOPs in all activities. Review and approve production batch records and associated documentation for Qualified Person disposition activities. Provide real-time quality oversight and support for production unit operations, extending to formulation, vial and syringe Fill Finish activities, including media fills and assessment of aseptic interventions. Conduct inspections of vials and syringes as part of AQLs, annual reserve inspections, and support complaint investigations. Offer Quality Assurance support for on-the-floor investigations and deviations. Review and approve deviations for closure, ensuring compliance with appropriate documentation. Participate in customer complaint investigations. Conduct routine Quality Assurance walks on the production floor. Review and issue logbooks, ensuring compliance with procedures. Provide training and guidance to staff for effective performance. Review and approve cGMP records, ensuring compliance with appropriate documentation. Support continuous improvement and Operational Excellence initiatives. Undertake other tasks/projects as assigned by the manager. Education and Experience: University degree in an Engineering or Science-related discipline (preferred). Over 4 years of relevant experience in the pharmaceutical or biotechnology industry or an equivalent combination of experience and educational background Demonstrated problem-solving abilities, particularly in supporting non-conformance/deviation investigations. Experience in inspecting vials and syringes and engaging in aseptic operations. If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information. TPBN1_IJ
Site Services Supervisor Ringaskiddy, Cork Our client is global organisation that sets science in motion, supporting life-changing therapies in a world-class manufacturing environment. This role offers real ownership, visibility and the opportunity to shape service delivery on a critical customer site. They are seeking a driven and accountable Site Services Supervisor to lead their on-site Laboratory Services Segment (LLS) team at a major biopharmaceutical manufacturing site in Ringaskiddy, Cork. This is a hands-on leadership role with full responsibility for operational delivery, team performance, customer satisfaction and compliance to Scope of Work (SOW), KPIs and regulatory standards. This is a full-time permanent position based at our clients customer site in Ringaskiddy, Cork. If you thrive in an accountable, customer-facing leadership role and want to combine operational control with strategic impact, we would like to hear from you. The Role Reporting to the Regional Operations Manager, you will lead a team of Material Controllers delivering Vendor Managed Inventory (VMI), stockroom and point-of-use services in a GMP-regulated manufacturing environment. You will act as the primary on-site operational contact for the customer, ensuring services are delivered safely, compliantly and in line with agreed Service Level Agreements (SLAs) and KPIs. This role combines operational oversight, people leadership, customer engagement and continuous improvement. Role/ Responsibilities: Operational Leadership Oversee daily VMI and stockroom operations across manufacturing and laboratory areas Plan and allocate workload to ensure service continuity and safe, on-time in-full (OTIF) delivery Ensure adherence to agreed Scope of Work and service boundaries Monitor task completion, audit readiness and documentation standards Customer & Stakeholder Management Act as key operational contact for site stakeholders and SPOCs Lead monthly operational reviews and contribute to quarterly business reviews Ensure timely communication of risks, delays or service issues Support contract governance, renewals and service optimisation initiatives Performance & Governance Own site-level KPIs, SLAs and performance reporting Conduct regular performance reviews with team members Maintain training matrix and ensure compliance with GMP, EHS and site policies Support audits and regulatory inspections as required People Management Lead, coach and develop a team of three on-site associates Drive engagement, accountability and cross-training Support recruitment, onboarding and succession planning Conduct structured one-to-ones and development discussions Continuous Improvement Identify and implement process improvements to enhance efficiency and service quality Partner with Commercial and Operations colleagues to support service growth opportunities Contribute to global LSS best practice sharing and standardisation Education/Experience: Education Leaving Certificate (minimum requirement) Level 7 degree or equivalent in Science, Supply Chain, Business or related discipline (desirable) Experience 35 years experience in a supervisory or leadership role Experience operating in a regulated (GMP/GLP) environment preferred Proven experience managing KPIs and delivering against SLAs Strong understanding of inventory control and stock management Experience in laboratory stockroom or pharmaceutical manufacturing environment advantageous Skills & Competencies Strong organisational and prioritisation skills Confident decision-maker in a fast-paced environment Excellent communication and stakeholder management capability High attention to detail and documentation discipline Proficiency in Excel and multiple IT systems full computer literacy required. Hands-on leadership style with willingness to support operational tasks Whats on offer Typical working hours: MondayFriday, 08:3017:00 Benefits: Competitive salary, performance-related bonus, 25 days annual leave, private health insurance, company pension. For further information please contact: Karen Shiel on or send CV to Skills: Inventory Management Site Services People Management Benefits: Pension, Bonus, Healthcare TPBN1_IJ
Validation Engineer RK26044 Contract 11 months Carlow Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Key Responsibilities: Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies in line with the standard approval process. Design/Author/Review/Approve/Execute Execution/development of change controls. Resolving technical issues encountered during study execution. Engagement with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities. Technical input into quality notification by authoring/reviewing/approving investigations. Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues. Support continuous improvement through Lean Six Sigma methodologies. Serve as validation representative for cross functional projects and represent the validation team at global technical forums Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around compliance Supporting regulatory audits and submissions as required. Education and Experience: 3-5 years direct experience with a pharmaceutical or biotechnology company Bachelors degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry etc. Strong experience in CTU equipment qualification, thermal mapping, equipment/process validation, and sterile fill-finish processes within GMP manufacturing environments. Skilled in deviation/change control management, technical project leadership, complex data analysis, and linking equipment performance to out-of-specification findings. Knowledge of GMP process monitoring, automation and data systems (e.g. DeltaV, PI System), regulatory/code compliance, and technical report/policy writing. If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information. TLNT1_IJ
Were currently recruiting for an exciting opportunity with an award-winning Biopharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties Developing single use systems in collaboration with site teams and network for DP formulation and filling. Authoring / verification of single use qualification packages. Filling characterisation support (Filling recipe development - protocol development / execution and reporting.) Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent Communication skills are essential for this role, as well as a demonstrated proficiency with the principles of Technical Writing. Leads and conducts risk assessment for drug product operations and propose / implement appropriate CAPA. Provide process development expertise for drug product processing in specific areas such as sterile processing, process characterization, filling, SUS. Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer. Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing. Troubleshoots issues with drug product processing technologies and equipment. Champions use of data-driven analyses and visualizations. Investigates to determine root cause. Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management. Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards). Review and post-approve process validation protocols and assessments from a quality system documentation perspective. Contribute to product quality assessments and process flow documents. Liaise with Operations, Engineering and external vendors regarding new or amended equipment which would impact the validated process. Education & Experience A third level Bachelors Degree in Science, Engineering or a relevant Quality discipline with 5 years experience in a similar role OR Masters degree & 3 years of directly related experience OR Associates degree & 10 years of directly related experience. Thorough knowledge of aseptic manufacturing technologies and cGMP. Strong skills in applying fundamental engineering and scientific principles to the design and implementation of Formulation Single use systems and Filling. Significant experience supporting Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Validation. Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of formulation, mixing, filtration and filling. Knowledge of protein biochemistry regarding chemical and physical stability Background in Drug product Filling technologies, Peristaltic pumping / Time pressure filling. If interested in this posting please feel free to contact Sen McCarthy on or for further information. TPBN1_IJ
