Position Overview Commissioning, Qualification and Validation (CQV) engineer for various capital and Equipment lifecycle projects joining a dynamic team. The role will be responsible for equipment validation in Sterile Fill Finish to ensure the maximum levels of performance and compliance are maintained. All activities are to be completed safely, on schedule and in compliance with GMP and Quality Requirements. Key Responsibilities Provide expert technical validation support to meet site objectives, comprising the full validation lifecycles process from initial design through qualification to validation maintenance (e.g., periodic review). Coordinate the qualification activities and maintain equipment and utility systems in a validated state. Develop or qualify approaches and equipment family strategies. Assist in the development of User Requirement Specifications (URS) and Quality Risk Assessment for equipment and automated systems (QRAES). Develop and approve C&Q / Validation Plans, FAT, SAT IV/FTs, QRAES, IOQs, PQs, etc. for the vial and syringe filling, formulation, inspection and utility areas in line with GMP, regulatory requirements and corporate standards. Ensure startup of equipment/utilities is completed in a safe and coordinated manner. Liaise with Engineering, Commissioning and Qualification, manufacturing, planning and PD and external vendors regarding equipment URS and Factory Acceptance Tests to ensure design‐by‑quality principles are followed. Support NPI introductions to equipment. Assist in the development and improvement of the equipment validation lifecycle process while ensuring continued compliance with all necessary regulations. Participate in regulatory inspections, regulatory filings and RTQs (response to questions). Update and maintain Standard Operating Procedures (SOP) in accordance with site and corporate requirements. Take ownership for quality compliance in all activities, ensuring approaches align with current guidelines (ICH/ASTM). Ensure the site change control procedure is adhered to. Education / Experience 6+ years experience in Science, Engineering or Validation, Commissioning and Qualification Management. Technical qualification at third level or equivalent in Engineering or science. Extensive knowledge and demonstrated experience managing Commissioning and Qualification for pharmaceutical/biotechnology projects. Strong understanding of a risk‑based approach to commissioning and qualification within the biotechnology industry. Experience with sterile/biotech equipment within the pharmaceutical industry is preferred. Experience qualifying filling, formulation and utility systems within the sterile manufacturing environment of drug product. Knowledge of safety, GMP and environmental regulatory requirements. Participate, when required, as a member of multidisciplinary site and multisite teams, e.g., Cross Functional Investigation Team or NPI regulatory marketing applications. #J-18808-Ljbffr
Recruitment by Aphex is seeking a candidate in Dublin for a role focusing on Process Development support for syringe filling and Single-Use Technologies. The ideal applicant will lead cross-functional teams, develop single-use systems, and ensure compliance with quality and regulatory standards. Key qualifications include a relevant degree and substantial experience in aseptic manufacturing and drug product processes. Excellent communication and problem-solving skills are essential. This role involves significant project leadership. #J-18808-Ljbffr
Overview Purpose This role will require the candidate to provide Process Development support for syringe filling and Single use technologies development for drug product Formulation & Filling processes. Key upcoming projects under this scope include characterisation and qualification of filling technology and new single use technology for 3 new syringe filling lines as part of the expansion project and new plant introduction. The candidate will provide technical support to large molecule and small molecule drug product manufacturing as well as part of the global Process Development (PD) organisation. Responsibilities 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 characterisation, filling, SUS. Troubleshoots issues with drug product processing technologies and equipment. Champions use of data-driven analyses and visualisations. Investigates to determine root cause. Lead or assist in deviation / exception resolution and root cause analysis. 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. Basic Qualifications A third level Bachelor\'s Degree in Science, Engineering or a relevant Quality discipline with 5 years\' experience in a similar role OR Master\'s degree & 3 years of directly related experience OR Associate\'s degree & 10 years of directly related experience. Knowledge of cGMPs and other worldwide regulatory requirements. Thorough knowledge of aseptic manufacturing technologies and cGMP. Problem solving ability and excellent oral and written communications skills Strong skills in applying fundamental engineering and scientific principles to the design and implementation of Formulation Single use systems and Filling. Preferred Qualifications 10 + years of experience in support of 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. Strong knowledge of Quality systems, Drug Product Manufacturing and Validation. Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent Communication skill is essential for this role. 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. #J-18808-Ljbffr
Purpose Join a supportive, growing team in the analysis of Biologics and Vaccines in a state-of-the-art Quality Operations laboratory. Carlow will manufacture and test biggest selling biologic and the biggest selling vaccine product and is a strategic manufacturing site. The QC Analyst / Senior Technician Quality Control will report directly to the QC Manager and will help us in the expansion of this Laboratory and complete analytical method transfers and validation as well as commercial testing. The lab operates a 2 cycle and 4 cycle shift and roles are available in both. Occasional travel may be required for training purposes. Responsibilities Work as directed by the Quality Control Manager according to Company safety policies, cGMP and cGLP. Required to drive compliance with Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc Participate in writing/revising/rolling out accurate operational procedures, training materials and maintenance procedures for various Quality systems; ensure all work is carried out in line with same Operate as part of the QC team performing the allocated testing and laboratory-based duties Perform various analytical techniques including but not limited to HPLC, (HIC, CE, IEX, HP-SEC), Capillary Electrophoresis and other compendial test methods in compliance with GMP requirements Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved Participate in the laboratory aspects of OOS investigations Provide support with audit/inspection requirements to ensure department compliance/readiness. Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility. Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 why's etc. Work collaboratively to drive a safe and compliant culture on site. Requirements Bachelors Degree or higher preferred; ideally in Analytical Chemistry/ Biochemistry or a closely related discipline The ideal candidate will have 2-3 years' experience in a pharmaceutical laboratory, ideally with experience in HPLC and relevant systems and software. Core to the role is to perform testing of samples to support the release of our key drug products. A good working knowledge of HPLC systems and software is desirable A good knowledge of cGMP, GLP, Quality Management Systems #J-18808-Ljbffr
Recruitment by Aphex is seeking a QC Analyst/Senior Technician Quality Control to join their team in Carlow, Ireland. The role involves working in a cutting-edge laboratory analyzing Biologics and Vaccines, driving compliance with GMP, and performing analytical testing with HPLC. Candidates should have a Bachelor's degree in Analytical Chemistry or Biochemistry and 2-3 years of lab experience. The position offers opportunities for continuous improvement and participation in audits and inspections. #J-18808-Ljbffr
Responsibilities Provide quality oversight and direction for the introduction of new products and materials, as well as manage external parties. Provide QA oversight to support Analytical, Warehouse and Facilities Management, including deviations, Root cause analysis, CAPAs and change controls Participate as a functional expert in the cross-functional team responsible for introducing products and materials at Carlow. Review documentation associated with new product and material introduction, such as Material Packs, QC Test Specifications, BOMs, Supplier Qualification and Oversight. Develop and monitor supplier performance metrics, participate in material review boards and quarterly reviews of key suppliers, and actively engage in cross-functional forums as needed. Maintain the approved supplier management list within the qualified Supplier Management system, ensuring correct setup of suppliers and materials used at Carlow. Support deviation and atypical closeout, as well as initiate and follow up on corrective and preventive actions. Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation. Conduct quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities. Serve as the point of contact for quality at both the site level and with external inputs, coordinating and attending Quality working group meetings. Facilitate compliance direction for the site by adhering to divisional policies, guidelines, and regulatory requirements. Proactively evaluate site compliance against emerging trends and initiate major compliance initiatives for improved status and operational efficiency. Actively participate in Plant/Quality committees and collaborate with other site functional groups. Requirements A minimum of 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment. Knowledge of regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices. Familiarity with cGMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice) is preferred. Strong report, standards, and policy writing skills. Experience with equipment and process validation. Familiarity with sterile filling processes and equipment. Proficiency in Microsoft Office and job-related computer applications. Experience or familiarity with Lean Six Sigma methodology is desired. Good collaboration skills and the ability to work effectively as part of a team to determine priorities. Demonstrated ability to work independently and take ownership of improvement initiatives with a moderate level of guidance. Proven ability to drive the completion of tasks. Strong decision-making capability with a sense of accountability and responsibility. Demonstrated problem-solving skills A Bachelor's degree or higher in a related Science discipline is preferred. #J-18808-Ljbffr
Recruitment by Aphex is seeking a quality oversight professional based in Carlow, Ireland. The role involves providing direction for new products in the pharmaceutical sector, managing QA processes, and ensuring compliance with regulatory standards. Candidates should have 3-5 years of quality experience and a Bachelor's degree in a related Science discipline. Familiarity with cGMP and GDP practices is preferred. Strong report writing and collaborative skills are essential for this position. #J-18808-Ljbffr
Purpose The Regulatory Affairs Department is responsible for managing products manufactured at Waterford from a regulatory perspective; ensuring submissions are submitted ontime, assessing change controls and deviations and ensuring regulatory compliance. Main responsibilities Maintenance of, and variations to, CMC Dossier for assigned products. Support and manage all regulatory requests impacting site products including coordination of site expert responses to support GRA in conclusion of request for information (RFI) activities as a result of deficiency letters (DLs) received from respective Health Authorities (HAs). Assess the regulatory impact of proposed changes by site for assigned products. Review and approval of Quality documentation including (but not limited to): batch records; specifications; plans; protocols/ technical reports; Standard Operating Procedures (SOPs), deviation assessments, and failure investigations for assigned products, as appropriate. Second RSO review for submission documentation. Track all site regulatory activities in real time within the site planning tracking tools. Monitor submission/approval status and track updates for assigned products. Participate in regulatory inspections/audits. Initial BLA/MAA authoring/coordination, as appropriate. Product Registration Renewals. Annual Reports e.g. US, Canada, Brazil. Periodic Quality Reviews (PQR). Contribute in project teams and provide regulatory guidance/ support. Takes ownership of product-related meetings i.e. core meeting on site/meeting with GRA/RSO counterparts in sister sites. Qualifications/Experience Experience: preferably 2 years+. Soft skills: Problem Solving, effective communication, critical thinking and time management. Technical skills: Experience of Regulatory Affairs, Manufacturing and/or Quality Operations, dealing with Health Authorities and working through corporate structure is desirable. Education: Degree in Science, Pharmacy or related discipline is essential. Languages: English. #J-18808-Ljbffr
Recruitment by Aphex is looking for a Regulatory Affairs professional in Waterford, Ireland. This role involves managing regulatory submissions, ensuring compliance, and supporting regulatory inspections. Candidates should have at least 2 years of experience, a degree in Science or Pharmacy, and strong problem-solving skills. Responsibilities include maintaining product dossiers, assessing regulatory changes, and participating in audits, all while ensuring effective communication throughout the process. #J-18808-Ljbffr
A biopharma recruitment agency is seeking a Project Portfolio Lead in Waterford, Ireland, to manage cross-functional teams and drive the introduction of new products. Candidates must have project management experience within the biopharma sector and knowledge of GMP requirements. The role involves leading project scope definition, stakeholder management, and change control tasks. This position offers an opportunity to significantly impact product development and process improvement in a regulated environment. #J-18808-Ljbffr
