Summary: Our client is a biopharmaceutical company based in Cork looking for a CQV Specialist to join its team. The successful candidate willLead/Execute/Participate in Equipment and System Validation Lifecycle processes, Qualification (IQ/OQ/PQ), Revalidation, Requalification and Equipment Periodic Reviews, for Equipment and Systems. Responsibilities: Coordinate with and guide other departments or outside contractors/vendors to complete validation tasks. Participate in CSV Validation Lifecycle processes, Qualification (RS/QAP/UAT etc), CSV Periodic Reviews, for Equipment and Systems. Participate and comply with the Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant. Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements. Execute/Participate in change controls and other compliance related tasks e.g. non-conformances. Support regulatory audits Lead/Support Shipping Qualification and/or Cleaning Verification/Validation activities Work on own initiative to maintain adherence to schedule of activities including run the business and project workloads. Support, lead or guide others in CQV projects. Qualifications & Experience: Hon. Degree in a Science or Engineering discipline. Minimum 5 years experience in a similar role. Experience in a GMP environment essential. Demonstrated knowledge in pharmaceutical/biopharmaceutical technicalmanufacturing operations, with experience of successfully delivering technical projects. Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory Demonstrated capability to deliver results RFT, in an FDA/HPRA Regulated production environment. Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels
Summary: A Process Engineer is required to join the Process Engineering Group on-site at a biopharmaceutical company in Carlow. The successful candidate will provide technical support for new product introductions (NPI) and commercial manufacturing. Responsibilities: Design/Author/Review/Approve/Execute qualification/validation documentation and process development studies in line with the standard approval process. Design/Author/Review/Approve/Execute Execution/development of change controls. Contribution to Kaizen events as appropriate. Technical input into quality notification by authoring/reviewing/approving investigations. Execution of equipment/qualification validation programs; including re-qualification and re-validation. Support continuous improvement through Lean Six Sigma methodologies. Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues. Serve as technical engineering representative for internal technical group discussions and represent technical Operations 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 action, participate in audits and inspections and proactively highlighting any issues around compliance. Qualifications & Experience: Bachelors Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline. Min 3 years experience ideally in manufacturing, preferably GMP setting. Evidence of continuous professional development is desirable. Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable but not a necessity. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. Report, standards, policy writing skills required. Equipment and process validation. Sterile filling processes and equipment. Proficiency in Microsoft Office and job-related computer applications required.
Summary: Our client is a pharmaceutical company based in South Dublin looking for a CQV Engineer to support the current and future pipeline of CAPEX Projects including but not limited toProcess and Packaging Equipment (OSD), Facilities and Utilities and Computerized Systems and Automation Packages Responsibilities: Prepare, review and approve documentation for cGMP / Validation regarding Equipment, Facility, Utility, Computerized Systems and Automation Packages and Manufacturing and Packaging Processes. Provide input into project phases from design, commissioning and qualification. Preparation, review and approval of Commissioning and Validation documentation. Document, resolve and assist in the closure of commissioning punch lists and validation deviations initiated during commissioning and qualification activities. Initiate and management of change control records. Evaluate quality standard of service providers for cGMP, including Validation requirements (Vendor qualification documentation). Vendor management during commissioning and qualification activities Compile, review and approve cGMP documentation Ensure up-to-date regulatory requirements for all validated operations Work with management and staff to foster an ethos and culture of cGMP & Quality awareness, where the cGMPs and Quality are an integral part of the overall business. Ensure site wide compliance to the cGMPs including data integrity. Management of validation schedules and timelines. Qualifications & Experience: Bachelors degree preferably in Engineering, Science or other technical field (engineering degree preferred). Minimum of 5 years related experience in pharmaceutical manufacturing environment, validation, operations, engineering, or any combination thereof. Experience in Production and or Packaging processes and control systems, process equipment, facilities and utilities. Experience in technical writing of GMP related documentation Experience in risk assessments drafting and risk based approach test protocol creation in relation to validation activities. Experience of Electronic Documentation Management Systems (KNEAT, VEEVA, TRACKWISE) Past experience writing, reviewing and executing validation documentation (Validation Plan, FAT, SAT, IQ, OQ, PQ, RTM, summary report) an advantage Strong tehnical writing ability a must (GMP Change Controls, GMPA Risk Assessment, drafting of VMPs, URSs, DQs, FATs, IOQs, IOQRs, GMPAs etc) Upgrade to high speed Capsule Filling equipment to accommodate granule handling New product introductions (NPI) in the drug product environment Upgrades to process equipment utilities & associated plant Upgrades to high speed Blisterline equipment (Uhlmann) New product introductions in the packaging environment, format parts General asset care equipment upgrades in all areas of packaging
Summary: Our client is a biopharmaceutical company in Waterford looking for a Process Engineer who will supportmanufacturing and drive development and implementation of improvement initiatives in the fill finish manufacturing and development operations. Responsibilities: Liaise with external and internal customers, suppliers and agencies to define and improve manufacturing and development operations Optimisation of manufacturing and development operations Identification & implementation of opportunities for improvements Assist in the implementation of capital projects Act as process lead for inspection development Lead technical problem resolution & RCA for all manufacturing operations, in conjunction with cross functional teams. Implementation and monitoring of performance metrics. Lead cycle time reduction initiatives in conjunction with manufacturing teams Implementation of best practice Process development programme design / plant trials, execution and implementation Constantly seeking to challenge operational standards and driving continuous improvement. Maintain required quality documents in a current compliant state. Resource for Clinical supply provision projects Aseptic manufacture or oral dose manufacture context Design and execution of experimental programmes Operation of process laboratories Scale-up and technology transfer project role Liaison for Clinical supply provision projects Liaison for new formulation and product enhancement programmes Technical representative for assessment and development of process change control and regulatory submission proposals Technical support and trouble-shooting in support of manufacturing activities Support of process qualification and process validation activities as required Qualifications & Experience: Degree in Chemical, Industrial or equivalent Engineering discipline Advanced degree in Pharmaceutics, Pharmacy or related science discipline considered an advantage 2 years + experience within Pharmaceutical Development and Manufacturing environment OEE/SMED/RCA/CI experience.Technical knowledge of aseptic manufacturing including lyophilisation considered an advantage Pharmaceutical product development project life-cycle Structured Problem-solving skills Statistical
Summary: A Senior QA Specialist is required for a biopharmaceutical company based in Athlone. The incumbent will be responsible for delivery of quality assurance activities to ensure commercial and clinical products are manufactured in accordance with cGMP, Corporate and Regulatory requirements. Responsibilities: Site QA responsibility to provide technical expertise for all QA and compliance topics / issues relating to sites manufacturing and product supply. Acts as quality point person, providing guidance and feedback on quality assurance issues. Performs timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk. Ensures schedules for review and approval of GMP documents are maintained to meet the needs of Clinical and Commercial Operations groups. Provide advice on GxP within the site, with reference to guidelines and regulations. Support technology transfers and new product introductions. Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives. Deliver Quality Assurance review and approval of SOPs, master batch records, policies, operational standards, validation protocols and reports as required. Provide quality oversight of Validation activities for the site. Support QP batch release activities to maintain release schedule. Actively support audit readiness activities and regulatory agency and internal audits. Actively contributes to continuous improvement activities. Lead coordination of referrals of regulatory documentation (e.g. dossiers, site impact assessment, annual reports, or QP declarations) and market-specific documentation for site accreditations and product reviews. Actively engage in process improvements and risk assessments, such as benchmarking internal and external quality assurance practices to identify innovative efficient and effective practices. Conduct data analysis and development of reports and insights on quality metrics and key performance indicators, using digital tools and processes. Support overall planning around quality training and guidance for internal / external stakeholders for area. Guide early-career team members around quality processes, related digital tools, and compliance requirements. Acts as delegate for QA management. Qualifications & Experience: Third level qualification e.g. B.Sc. in science/pharmacy. A minimum of 7 years relevant experience within the pharma industry or a related field. Strong knowledge of cGMP requirements for pharmaceutical manufacturing and/or packaging required. Direct experience of New Product Introduction required. Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable. Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA/EMA or other authorities of similar standing. Experience with quality processes across multiple areas. Experience interpreting and guiding team members around principles and concepts of compliance management within a regulated environment. Experience troubleshooting issues across quality areas. Experience implementing newer digital tools and technologies related to QA reporting, documentation, and analysis. Good knowledge of relevant computer packages e.g. TrackWise or similar. High level technical skills including analytical, auditing, pharmaceutical manufacturing and regulatory inspection management. Technical writing skills required.
Summary: We are seeking aConstruction Manager (Client Side) who will play a critical role in the successful delivery of a pharmaceutical site expansion and fit-out project. This role will ensure that all construction activities are executed safely, efficiently, and in full compliance with GMP, local regulations, and company standards. The Construction Manager will interface with client stakeholders, and contractor organisations to ensure all works are delivered to scope, on schedule, within budget, and to the highest quality standards. Responsibilities: Act as the primary on-site client representative, ensuring alignment between contractors, consultants, and internal stakeholders. Work collaboratively with the SHE team, Facilities, and Operations to minimize disruption to ongoing pharmaceutical production. Ensure construction works meet GMP, building regulations, and internal quality standards. Support validation and engineering teams with handover readiness documentation. Promote a strong safety culture on site, ensuring adherence to all EHS requirements and company policies. Review incident reports, conduct site safety walks, and ensure corrective actions are implemented promptly. Provide regular progress reports covering safety, quality, schedule, risk, and cost. Foster strong relationships with design consultants, contractors, and the client project team. Lead or participate in weekly progress and coordination meetings, escalating issues as required. Support handover to local site operations, including facilitating signoff by the client representatives. Qualifications & Experience: Degree in Construction Management, Engineering, Architecture, or a related discipline. 10+ years experience in construction management, preferably on pharmaceutical or biopharmaceutical sites. Proven experience delivering fit-out and infrastructure upgrade projects within a live GMP environment. Strong working knowledge of GMP, EHS legislation, and construction best practices. Proficiency in MS Word, Excel, PowerPoint, Teams, MSProject and SharePoint Excellent communication, coordination, and stakeholder management skills.
Summary: Our client, a pharmaceutical manufacturing company located in North Wicklow, is seeking a Project Manager to lead end-to-end delivery of medium to large-scale processing equipment and facility projects. This role manages full lifecycle project activities, including scope definition, design, procurement, installation, commissioning and handover. The successful candidate will support new product introduction projects, process equipment upgrades, and utility modifications within a GMP environment. Responsibilities: Lead full lifecycle project management for processing equipment and associated utilities, from concept through to handover. Ensure projects are delivered safely, on time, within budget and in line with GMP and engineering standards. Oversee development of project documentation, including design packages, schedules, budgets, procurement plans and progress reports. Coordinate cross-functional teams including Engineering, Operations, Quality, EHS, Procurement and external partners. Manage equipment specification, vendor selection, factory and site acceptance, installation and qualification activities. Support preparation of business cases and capital applications. Drive structured problem-solving and risk mitigation throughout project execution. Ensure compliance with quality systems, change management processes and safety requirements. Provide on-site oversight during installation and commissioning, ensuring adherence to design intent and operational needs. Support training and transition of new systems to end users. Qualifications & Experience: Bachelors degree in Engineering, Science or related technical discipline. Minimum 10 years experience delivering capital projects in pharmaceutical or biotech manufacturing. Proven experience managing equipment and facility projects up to approximately €3M. Strong understanding of GMP, engineering design, equipment installation and commissioning. Experience managing external contractors and equipment vendors. Strong communication, leadership and stakeholder engagement skills. Experience in scheduling, cost estimation and project controls. Project management certification (PMP/IPMA) is an advantage.
Summary: We currently have an opportunity for an Electrical Engineer to join our team. The successful candidate will support a variety of projects in the pharmaceutical, biopharmaceutical and medical device industries. Responsibilities: Delivery of projects including detailed design, scope issue, field construction and commissioning through to handover. Will be involved in the preparation of cost estimates for clients including timelines and justifications. Carry out site surveys. Carry out the design of areas such as lighting, small power, fire alarms, LV distribution and cable sizing etc. Assist with the preparation of projects schedules and monitor progress, ensuring critical path is maintained and implementing mitigation plans as necessary. Help develop a strong safety culture within the company, proactively drive towards continuous improvement and achieving best in class standards. Generate User Requirements Specifications with stakeholders. Review design packages from consultants. Involvement in the issuing of tender enquiries for consultants, contractors and vendors. Interface with project management and project engineers during the design, execution and start-up phase of projects. Support field installation and commissioning of larger projects. Qualifications & Experience: Degree in Electrical Engineering or similar. Minimum 3 years post graduate experience in project delivery in a medical device or pharmaceutical manufacturing environment. Working knowledge of CAD a distinct advantage. Technical knowledge of MV and LV power infrastructure, Building Management Systems (BMS), data and IT infrastructure. Project planning, design, cost control. Ability to coordinate of multiple stakeholders, contractors and vendors.
Summary: Our client, a pharmaceutical manufacturing company located in North Wicklow, is seeking a Project Manager to support packaging equipment upgrades, asset care initiatives and new product introduction activities within a pharmaceutical packaging environment. The role includes leading full lifecycle delivery of packaging-related capital projects and ensuring compliance with GMP, engineering and safety standards. Responsibilities: Manage all phases of packaging equipment projects, including concept development, basic and detailed design, procurement, installation, commissioning and qualification. Deliver high-speed packaging line upgrades, format part changes and general asset care improvements. Ensure adherence to project scope, schedule and budget while maintaining compliance with GMP, engineering and safety requirements. Coordinate the activities of internal stakeholders and external suppliers across packaging, engineering, quality and operations. Prepare and maintain project documentation including project plans, technical specifications, risk assessments and status reports. Lead risk management activities and facilitate issue resolution across project teams. Support capital approval processes and development of project justification packages. Oversee CQV activities and ensure readiness for operational handover and training. Ensure compliance with site quality systems, procurement governance and safety procedures. Qualifications & Experience: Bachelors degree in Engineering, Science or a related technical field. Minimum 10 years experience managing packaging or equipment-related capital projects in pharmaceutical manufacturing. Experience delivering full lifecycle equipment projects up to approximately €3M. Strong knowledge of packaging processes, automation interfaces and equipment design documentation. Experience working with equipment vendors and contract engineers. Proficiency in project planning, scheduling and cost control. Strong stakeholder engagement, communication and problem-solving skills. Project management certification (PMP/IPMA) is an advantage.
Summary: A leading Biopharma company in Limerick is seeking a Projects Safety Advisor ensuring compliance with EHS requirements, supporting project teams on site, and ensuring that documentation, procedures, and quality standards are fully implemented and adhered to. Responsibilities: Lead and coordinate Environmental, Health and Safety (EHS) programmes across all CAPEX projects. Provide EHS support and oversight to project teams, ensuring compliance with company standards, Irish legislation, and industry best practice. Participate in all project phases, offering guidance on design-stage safety, construction activities, commissioning, and handover. Develop, review, and maintain project EHS documentation, including risk assessments, method statements, safe systems of work, and project safety files. Identify project-related hazards and design suitable control measures, ensuring risks are effectively communicated and implemented. Conduct regular site inspections, audits, and performance reviews to monitor compliance and drive continuous improvement. Liaise with vendors, contractors, and internal stakeholders to ensure alignment with EHS requirements and verify accurate documentation. Support the creation and review of Construction EHS Plans in collaboration with Project Managers. Deliver EHS training, briefings, and toolbox talks to project engineers, managers, and contractors as required. Contribute to incident investigations, root-cause analysis, and corrective actions to prevent recurrence. Promote a proactive safety culture within the Projects Group by driving engagement, awareness, and accountability. Responsible for regulatory submissions to the HSA. Qualifications & Experience: Third-level qualification in Occupational Safety, Health, Environmental Science, or a related discipline. Minimum of 5 years experience in an EHS role, ideally within the biopharma, pharmaceutical, or life sciences sector. PSCS and PSDP experience a distinct advantage. Proactive approach to risk management, with a focus on quality, compliance, and continuous improvement.
