Recruitment by Aphex is offering an Engineering Specialist (Validation) position in Carlow, Ireland. The role involves supporting multiple aspects of validation processes, including design, execution of qualification documentation, and cross-functional project participation. Ideal candidates will have relevant technical qualifications in engineering or pharmaceutical sciences, along with a proven track record in technical project leadership and knowledge of GMP standards. Strong communication and problem-solving skills are essential. #J-18808-Ljbffr
Purpose We are seeking an experienced Utilities Engineer for our client to act as System Owner for key utility systems within the Site F&E (Facilities & Engineering) group. The successful candidate will take full ownership of assigned systems, ensuring they remain safe, compliant, and operating at optimal performance. This is a hands‑on, high‑accountability role requiring the ability to work independently, engage cross‑functionally, and maintain inspection readiness at all times. Key Responsibilities System Ownership & Operations Own day‑to‑day performance of assigned utility systems Monitor, trend, and optimise system performance and uptime Troubleshoot issues and implement timely, effective resolutions Co‑ordinate and manage vendors and ensure preventive maintenance is executed effectively Maintain oversight of critical spare parts and asset reliability Identify and implement practical improvements to system reliability and performance Apply data‑driven approaches to resolve recurring issues Support optimisation of maintenance strategies (preventive / predictive Review and approve SOPs, change controls, and technical documentation Execute and manage CMMS work orders related to owned systems Rolling out training on systems and ensuring all documentation is accurate, current, and audit‑ready Ownership of interactions, understanding of the interface of their systems with the Client or PCS systems on site Quality & Compliance Lead and close out deviations, non‑conformances, and CAPAs, including RCA ownership All design reviews associated with equipment purchases and review/approval of changes to their systems Support Quality System triage activities Ensure systems are maintained in an inspection‑ready state and act as SME during audits and regulatory inspections Cross‑Functional / Project & Upgrade Support Interface with Manufacturing, QA, Labs, and EHS on system performance and issues Provide clear technical input to support operational decision‑making Represent Utilities in cross‑functional meetings as required Support ongoing site projects (e.g. WC Labs upgrade) as required Contribute to development of execution FAT, SAT, and IOQ deliverables Review and support system changes and upgrades Qualifications / experience Bachelor's degree in Engineering (Mechanical, Electrical, Chemical or related) Strong experience in GMP‑regulated pharmaceutical or biotech environments Proven experience operating / troubleshooting utility systems (e.g. HVAC, WFI, clean utilities, process utilities) Demonstrated experience in deviations, CAPAs, and root cause analysis Ability to work independently with minimal supervision Preferred Previous System Owner / SME experience Experience supporting regulatory inspections and audits Familiarity with Client / PCS / automation systems and understanding of the interface of their systems Experience in GMP qualification (FAT/SAT/IOQ) and involvement in capital projects or site upgrades #J-18808-Ljbffr
Recruitment by Aphex is looking for a candidate to support the qualification of a new production facility in Dublin. The role involves writing qualification documents, SOPs, and trend reports, while ensuring adherence to cGMP and GLP requirements. Ideal candidates should have a Bachelor's degree in a science discipline and biopharmaceutical QC experience, especially in environmental monitoring within aseptic cleanrooms. Excellent communication and problem-solving skills are essential for this position. #J-18808-Ljbffr
Recruitment by Aphex is looking for a finance professional in Dublin to manage budgets and provide financial decision support. The ideal candidate will have over 5 years of experience, a Bachelor's degree in Accounting or Finance, and fluency in English. Strong knowledge of SAP and other financial tools is required. Responsibilities include month-end close activities, supporting audits, and managing financial reporting. This role offers the chance to work in an international environment within biotechnology or pharmaceuticals. #J-18808-Ljbffr
Purpose This role will require the candidate to provide process development support primarily to new product introductions (NPI) and lifecycle management (LCM) changes. In addition, the candidate will be expected to provide technical support to biologics drug product manufacturing. With the intention of moving to a new building construction that will house single use end to end processes and new syringe fillers. Responsibilities Support and/lead new product introductions from concept to PPQ form a Process Development perspective and complete product filings. Be accountable for success of the product transfer project from initiation to the transfer, through line characterisation, engineering studies, process performance qualification and ultimately to regulatory approval. Provide solutions when trouble shooting drug substance freezing/thawing, formulation, filling syringes, inspection and transportation for parenteral products through the NPI or post-NPI phases. Provide process development knowledge for commercial drug product processing in specific areas such as sterile processing, process characterisation, tech transfer and validation and input on design for new parts of the facility where needed. Support commercial drug product manufacturing operations with technical evaluation of Change Control/NC/CAPA and technology transfer. The position will report to Process Development Manager. Moderate international travel might be required during the course of the project(s). Key Responsibilities Development of characterisation studies, engineering runs, electronic batch record creation, validation plans, process performance qualifications for syringe filling. Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training. Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards) with a full understanding of CMC business process related to technology transfer. Participate in process validation cross functional teams at the site to ensure adherence to required policies and procedures and be responsible to deliver against organizational goals and project milestones. Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective. Actively communicates across functions and sites and is a strong collaborator with all the functional groups at the receiving site, sending site and corporate functions. Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations and input to site validation guidance documents. Collate and report on relevant shipping and filter validation. Assist in deviation and exception resolution and root cause analysis. Contribute to product quality assessments and process flow documents. Basic Qualifications Third level Bachelor's degree in science, engineering or equivalent discipline with 5 years experience in a commercial manufacturing or NPI role. Knowledge of cGMPs and other worldwide regulatory requirements. Problem solving ability and excellent oral and written communications skills. Preferred Qualifications Doctorate or Masters in Science or Engineering. 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 protein freeze-thawing, filtration, mixing, filling (PpK / batch homogeneity). Knowledge of protein biochemistry with regard to chemical and physical stability. Project management skills including the ability to manage multiple projects and evaluate project resource requirements. 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 skills are essential for this role. The successful candidate will need to be prepared to participate in 24/7 support once or twice a quarter (depending on business needs) for approx. 1-2 weeks at a time. 35% shift rate applies. Confirmed shift pattern: Its 2 days on 7am-7pm, 2 nights on 7pm-7am, 4 days off. #J-18808-Ljbffr
Recruitment by Aphex is looking for an experienced Utilities Engineer in Dublin, Ireland. The role involves full ownership of key utility systems within Site Facilities & Engineering, ensuring safety, compliance, and optimal performance. Applicants should hold a Bachelor's in Engineering and possess significant GMP-regulated experience, particularly in utility systems. The position emphasizes strong troubleshooting, cross-functional collaboration, and effective data-driven approaches. Ideal candidates are proactive, independent workers with a focus on ensuring inspection readiness. #J-18808-Ljbffr
Responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities. Responsible for ensuring that all maintenance & calibration activities carried out by Calibration Technicians are tracked & managed through the Computerised Maintenance Management System (CMMS) Maximo. Responsible for authoring/owning and approving Validation Life Cycle documents for computer related systems including responsibility for Data Integrity testing and business administration of Laboratory Computer Related systems. Responsible for the execution of protocols once approved. Candidate should have specific hands-on laboratory equipment lifecycle and validation experience. Key Responsibilities 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 manager's request. Knowledge and Experience Bachelor's 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. Detailed knowledge of the methodology, 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. The successful candidates will be involved with routine activities and may be requested to support project work. For the most part project work consists of the introduction and qualification of analytical equipment for use in routine QC analysis and the candidate should have specific hands-on laboratory equipment lifecycle and validation. #J-18808-Ljbffr
Purpose We now have an excellent opportunity with our client in their Lending team. The primary role of the team is to deal with the underwriting, processing and approval / referral of loan applications received from members. The team also deals with overdraft, reschedule, mortgage & business applications. Staff from the team constitute the Combined Authority and decide on applications as required by policy. The Team also provides support to the Credit Committee and Board of Directors in relation to loan applications and lending related issues. The Senior Loans Officer will have a variety of duties within the Lending Team. They will be required to provide support to members of the team, both administrative and technical. Responsibilities Assess credit applications including personal, business, overdraft, reschedules and, if required, mortgage applications. Review borrower's ability to repay. Assemble the paperwork associated with the application. Review credit reports, e.g. CCR reports. Analyse applicants' financial circumstances. Analyse self employed applicants’ financial circumstances, if/when required. Conduct stress tests as required. Approving loan applications within approval authorities / policy. Contacting members relating to ongoing applications / decision outcomes. Reviewing applications to extend / reschedule agreements. Preparing and presenting complex loan applications to the Lending Team Manager /Combined Authority / Credit Committee / Board. Processing loan applications on computer systems to reflect ongoing requests and Loans Officers / Committees’ decisions. Dealing with Business Loan queries through to application. Deputise for Lending Team Assistant Managers in their absence, as required. Making appropriate decisions and taking appropriate actions to support the smooth running of the Lending Team. Communicating any such decisions / actions to the Lending Team, Assistant Lending Manager -Senior Lending, as required. Contributing to the credit policy as part of the team discussions. Assisting with / participating on Board Committees, in particular, but not limited to; the Credit Committee, if required. Administrative duties associated with the work of the team. Ensure that appropriate controls are maintained on the work and that the Assistant Manager Senior Lending is kept informed, particularly where there is deviation from the agreed time frames or policies. To support, promote and actively participate in sustainable energy, water and waste initiatives to create a more sustainable, low carbon and efficient Credit Union. Any other duties that may be required. Qualifications / Experience Must hold at a minimum an APA in Loans, Savings and investments or equivalent that also satisfies the Minimum Competency Qualification in line with the requirements of the Central Bank of Ireland’s Minimum Competency Code. 2-3 years personal loan underwriting experience is required. Meet & Satisfy Fitness and Probity requirements. A relevant third level or professional qualification is an advantage. Good working knowledge of Wellington IT (Scion) is an advantage. #J-18808-Ljbffr
Purpose The Operational Readiness Sr. Associate is responsible for ensuring operational readiness by supporting cross-functional execution across all major milestones (FAT - SAT - FT - AVS - EMPQ - Media Fill - PPQ), maintaining clear line-of-sight to readiness requirements and deliverables. The person in this role will enable day-to-day execution by coordinating inputs across Manufacturing, Quality, Engineering, EHS and other stakeholders, ensuring dependencies are understood, decisions are actioned, and readiness activities remain on track. The Operational Readiness Sr. Associate will monitor compliance and adherence metrics (e.g., milestone readiness, action closure, training and documentation status), provide timely visibility to leadership, and elevate risks, gaps, or non-conformances to sustain safe, compliant, and reliable operations. Key Responsibilities Support Operational Readiness Execution Support operational readiness planning and execution across all key milestones. Maintain a forward-looking view of execution needs (12-18 months) to ensure equipment, commissioning, qualification and manufacturing preparedness activities are sequenced to enable safe start-up and reliable operations. Align Manufacturing, Quality, Engineering, EHS and other functional readiness plans into a single execution rhythm, ensuring handoffs, constraints and critical dependencies are understood and actively managed. Provide clear visibility of readiness status, identify operational risks and elevate emerging issues to maintain compliance, safety and reliability. Establish consistent ways of working for readiness reviews, decision logging and action closure to keep teams aligned and accountable. Progress Tracking & Performance Management The Operational Readiness Sr. Associate should establish and enforce structured progress tracking mechanisms across all workstreams. They should ensure timely updates from functional teams and validate accuracy of reported progress, track milestone readiness and ensure alignment with overall project timelines. They should hold teams to account through identifying performance gaps and drive accountability with stakeholders. They will support regular reporting cycles with accurate, data-driven insights, proactively identify schedule risks, bottlenecks, and dependency conflicts. The Operational Readiness Sr. Associate must elevate risks that could impact critical milestones such as Media Fill or PPQ and should partner with stakeholders to define mitigation plans and track resolution. They should ensure all functions are aligned to a single integrated schedule and planning framework and act as a central coordination point for schedule-related decision-making. The role requires to be at least 3 days onsite per week. Qualifications/Experience Educational background: Level 8 or Bachelor's degree in Science or Engineering Experience building and maintaining dashboards and data visualizations. MS Office and Project Management Computer Skills Understanding of project lifecycle phases (commissioning, qualification, etc.) Key Skills & Experience/ Preferred requirement Strong understanding of project lifecycle phases (commissioning, qualification, etc.) Ability to manage complex, cross-functional dependencies. Strong analytical and problem-solving skills. Excellent stakeholder management and communication skills. AI mindset Prior Manufacturing experience or relevant experience in pharma/biotech or large-scale project environments preferred. #J-18808-Ljbffr
Purpose The Quality Assurance Specialist within the Company is required to Work a 4 shift pattern role Technical knowledge of sterile manufacturing processes Perform timely reviews of batch documentation / investigations/ reports highlighting and assist in the resolution of concerns commensurate with the risk Respond quickly to unplanned events, technical issues Operational experience of quality systems in a dynamic manufacturing environment eg SAP, Trackwise, MES Full understanding of relevant quality and compliance regulations knowledge of requirements for cGMP, US and EU regulatory requirements Conduct, report and display of Quality right first time, audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance Support the spot check/walk-through process of the production lines Involved in customer complaint investigation if required 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 (EBR’s) / 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. Qualifications Bachelor's 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 Knowledge of cGMP and GDP essential Report, standards, policy writing skills required Competent in the use of MES and SAP The position is onsite and remote or hybrid is not applicable for this role. This is a shift position - 4 cycle - 12 hours per shift e.g. Shift Schedule Week 1- long week: Monday - Tuesday Days, Friday, Sat, Sun nights Week 2- short week: Wed and Thurs Days, Week 3: Long week: Monday - Tuesday nights, Friday, Sat and Sun Days Week 4: short week: Wednesday and Thurs Nights #J-18808-Ljbffr
