Our client is a prominent API manufacturing facility based in Ireland. As the site expands with a new building and prepares for a significant increase in production capacity, they are seeking a high-level specialist to spearhead their cleaning validation strategy. This is a critical time for the site as they transition into a more robust, formal policy framework for their manufacturing processes. Reporting directly to the Validation Manager , you will act as the technical lead and subject matter expert for cleaning validation on-site. Responsibilities Strategic Development: Consult for cleaning validation on-site, developing and implementing a site-wide policy from the ground up. Execution: Lead and carry out various cleaning studies to ensure API processes are compliant, efficient, and "neat." Compliance: Ensure all strategies meet the rigorous standards of HPRA and FDA regulations. Consultancy: Provide expert-level guidance to ensure the new building's cleaning validation is integrated seamlessly into site operations. Experience We are seeking a seasoned expert who can slot straight in and provide immediate consultancy-level value. Experience: 10+ years experience in Cleaning Validation. Expertise: Deep knowledge of HPRA/FDA audit requirements and a proven track record of successful audit outcomes. Skills: Ability to work autonomously to establish formal policies and provide high-level guidance to the wider validation team. Flexibility: Part-time schedule (2 days per week) with hybrid/remote working options available. #J-18808-Ljbffr
We are partnering with a leading pharmaceutical manufacturing organisation to appoint a Maintenance & Utilities Lead for a critical site-based role. This is a senior, hands‑on engineering leadership position with full responsibility for maintenance, utilities, and reliability across a complex GMP‑regulated environment. Reporting to the Site Engineering Manager, the successful candidate will play a key role in ensuring asset reliability, maximising uptime, and supporting production delivery across multiple manufacturing modules. This is a broad and high‑impact role requiring a technically credible leader who can operate at both strategic and operational levels - driving performance, leading teams, managing vendors, and fronting audits and regulatory interactions. This organisation develops and manufactures innovative therapeutics for patients with rare health conditions, with a strong commitment to quality, science, and responsible operations. Responsibilties Lead all maintenance and utilities activities across the site, ensuring high equipment reliability and uptime Own and optimise preventative and corrective maintenance programmes across process and utility systems Manage and develop a multidisciplinary team including technicians, engineers, and third‑party vendors Oversee utility systems including HVAC, clean utilities (e.g. purified water, steam), and site services Drive reliability initiatives and continuous improvement programmes across engineering systems Act as SME during audits and inspections, supporting regulatory compliance (GMP, EHS, ISO, etc.) Manage engineering KPIs, performance metrics, and maintenance systems (e.g. CMMS) Lead troubleshooting, root cause analysis, and deviation investigations across equipment and utilities Own and manage the engineering maintenance budget Coordinate vendor activities and ensure service delivery standards are maintained Manage the on‑call engineering structure and support out‑of‑hours escalation as required Collaborate cross‑functionally with operations, quality, validation, and engineering teams Prepare and present technical reports, including audit readiness and system performance updates Experience 8-10+ years' experience in a maintenance, utilities, or engineering leadership role within pharma, biotech, or API manufacturing Strong working knowledge of GMP environments, audits, and regulatory compliance Proven experience managing maintenance and utility systems in a manufacturing setting Demonstrated people leadership experience across technicians, engineers, and contractors Technically strong with experience across key systems such as HVAC, purified water, steam, and process utilities Experience with CMMS platforms (e.g. SAP, Maximo, Blue Mountain or similar) Familiarity with automation and control systems (e.g. BMS, process control platforms) Experience driving reliability, uptime, and continuous improvement initiatives (Lean, KPIs, structured problem solving) Strong communication skills with the ability to present to both technical and non‑technical stakeholders Degree‑qualified in engineering or a related technical discipline Attractive benefits package #J-18808-Ljbffr
The Position The Project Engineer will lead a critical facility upgrade project involving the end-to-end replacement of an onsite Autoclave, including the associated Steam Generation and Reverse Osmosis (RO) systems. You will be responsible for the full project lifecycle, ensuring all equipment is installed, commissioned, and validated in compliance with FDA and HPRA regulatory standards. Manage the full project lifecycle from initial concept and URS generation through to final handover to production. Oversee the decommissioning of legacy units and the installation of a new Autoclave, Pure Steam Generator, and Reverse Osmosis water system. Produce and approve technical documentation, including red-lined P&IDs for steam generation, purified water, and facility utility hook-ups. Lead vendor selection and manage equipment suppliers through design reviews, FAT, and SAT. Execute and manage IQ/OQ/PQ protocols to ensure the autoclave and water systems meet sterilisation and purity requirements. Lead a cross-functional team (QA, Validation, EHS, and Production) to ensure project activities do not impact ongoing manufacturing schedules. Maintain full CAPEX responsibility for the project budget while ensuring all work adheres to GMP and safety standards. The Person B.Eng in Mechanical or Process Engineering (or a related discipline) Hands-on experience with the operation, maintenance, and control of Autoclaves and Clean Steam systems. Deep understanding of pure water systems (RO/Purified Water), steam generation, and industrial boilers. Proficiency in GxP environments, 21 CFR Part 11, and the validation requirements for aseptic manufacturing equipment. Demonstrated ability to troubleshoot combined mechanical, pneumatic, and PLC-controlled utility systems. To discover more about this opportunity please apply online or contact Darragh on +353 87 9345234 for a confidential discussion. #J-18808-Ljbffr
Our client, a leading API manufacturer , is currently undergoing a significant Digital Transformation . With several major computer systems set to go live between now and 2027, the site is moving toward a more sophisticated, digital-first manufacturing environment, primarily focused on modernizing their andscape. The Position Reporting to the Validation Manager , the CSV Consultant will be the technical anchor for this digital evolution. You will play a pivotal role in ensuring new digital systems meet global regulatory standards. Key Responsibilities Project Leadership: Lead the validation of various computer systems, specifically managing the high-priority SAP S4HANA migration. Compliance Management: Ensure all systems adhere to Annex 11 and GAMP 5 standards throughout the project lifecycle. Lifecycle Documentation: Maintain and manage CSV lifecycle documentation for all new digital systems. Audit Readiness: Ensure all computer systems are fully prepared for scrutiny during HPRA and FDA inspections. The Person The ideal candidate will be a technical leader with extensive experience in large-scale digital migrations and computer systems compliance. Experience: 10+ years experience in Computer Systems Validation (CSV). Systems Knowledge: Proven experience with SAP/S4HANA migrations is essential. Regulatory Knowledge: Expert-level understanding of Annex 11, GAMP 5, and international regulatory expectations. Audit Background: A strong history of representing CSV processes during HPRA/FDA audits. The Benefits Flexibility: Part-time schedule (2 days per week) to support ongoing project milestones. #J-18808-Ljbffr
A leading API manufacturer in Ireland is looking for a CSV Consultant to spearhead their digital transformation. You will report to the Validation Manager and ensure new digital systems comply with global regulatory standards. Key responsibilities include leading the validation of computer systems and managing compliance with Annex 11 and GAMP 5. The ideal candidate has over 10 years of experience in Computer Systems Validation and a strong history in audit management. A part-time work schedule is offered, providing flexibility to meet project milestones. #J-18808-Ljbffr
A global leader in animal health, developing and providing vaccines, medicines, diagnostics, and technologies for both livestock and companion animals. Responsibilities Lead the validation activities for Siemens PCS7 systems, including the authoring and execution of Validation Plans, User Requirement Specifications (URS), Functional Specifications (FS), and Design Specifications (DS). Draft, review, and execute IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols for PCS7-controlled equipment and software updates. Act as a Subject Matter Expert for Data Integrity (ALCOA+), ensuring that PCS7 audit trails, user access levels, and data storage systems meet strict regulatory requirements. Conduct System Impact Assessments and Quality Risk Assessments to identify critical system functionalities and mitigate risks related to patient safety and product quality. Manage technical change controls for automation upgrades and lead investigations into deviations or non-conformances related to computerised systems. Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) at vendor sites for new PCS7-based skid equipment. Experience Bachelor's degree in Engineering (Automation, Electrical, or Chemical), Computer Science, or a related Life Sciences discipline. 3-5+ years of CSV experience in a GxP environment (Pharma/Med-Device). Demonstrated experience validating Siemens SIMATIC PCS7 systems, including familiarity with WinCC (SCADA), Step 7, and Batch operations. Deep understanding of GAMP 5 (Risk-based approach), 21 CFR Part 11, and EU Annex 11. Familiarity with PLC/DCS architectures, industrial networks (Profinet/Profibus), and historian systems (e.g. OSIsoft PI) is highly desirable. #J-18808-Ljbffr
A recruitment consultancy seeks a Project Engineer in Wicklow, Ireland, to lead a critical facility upgrade project. You will manage the lifecycle of replacing an onsite Autoclave and steam systems, ensuring compliance with FDA and HPRA standards. The ideal candidate holds a B.Eng in Mechanical or Process Engineering and has hands-on experience with Autoclaves and Clean Steam systems. Responsibilities include managing project budgets, overseeing installations, and collaborating with cross-functional teams. This role is vital for maintaining compliance and safety standards. #J-18808-Ljbffr
A leading pharmaceutical manufacturing organization in Dublin seeks a Maintenance & Utilities Lead for a site-based engineering leadership role. Responsibilities include overseeing maintenance activities, managing a multidisciplinary team, and ensuring compliance with GMP regulations. Candidates should have 8-10+ years in a similar role, a strong technical background, and experience with HVAC and utility systems. This role offers an opportunity to drive reliability initiatives and lead continuous improvement efforts. #J-18808-Ljbffr
A leading recruitment agency is looking for a Cleaning Validation Specialist to support an API manufacturing facility in Ireland. This role involves strategic development, execution of cleaning studies, and ensuring compliance with HPRA and FDA regulations. The ideal candidate should have over 10 years of experience in Cleaning Validation and be able to provide immediate consultancy-level value. The position offers a part-time schedule with hybrid or remote working options. #J-18808-Ljbffr
A global leader in animal health in Ireland is seeking an experienced professional to lead validation activities for Siemens PCS7 systems. The role involves drafting and executing validation protocols and ensuring compliance with regulatory standards. Ideal candidates will have a degree in engineering or related fields and 3-5 years of CSV experience in GxP environments. Familiarity with PLC/DCS architectures and data integrity principles is essential for this position. #J-18808-Ljbffr
