CQV Clean Utilities Engineer – Ireland (Contract) Greenfield Pharma Project | High-Impact Facility | Immediate Start I’m currently supporting a major pharmaceutical client on one of the largest greenfield fill-finish projects in Ireland, and we’re looking for an experienced CQV Clean Utilities Engineer to join the team. This is a hands-on, site-based role in a fast-paced execution / start-up phase, ideal for someone who thrives in the field and can drive systems over the line. Location: Co. Kerry (on-site) Project: Greenfield sterile fill-finish facility (oncology products) Duration: Initial 6 months (realistically 8–12 months+) Role Responsibilities Generation & execution of URS, QRA, RTM, IOV & IOQ protocols P&ID walkdowns and W3 execution with construction teams Hands-on startup, energization, shakedown & OV testing Review of TTOPs & Construction System Dossiers (CSDs) Participation / leadership in field whiteboard meetings Managing deviations through to closure Working cross-functionally with Automation, Vendors & Client teams Required Experience Strong CQV background in clean utilities (WFI, PW, Clean Steam, gases) Proven field execution experience on large GMP projects Experience from startup through qualification phases Solid understanding of GMP / GDP (Annex 1, 15, 21 CFR Part 210/211) Ability to challenge vendors and take ownership on site If you’re interested (or know someone who is), feel free to reach out directly or apply below. #J-18808-Ljbffr
Optimus Life Sciences is seeking an experienced CQV Clean Utilities Engineer for a greenfield pharma project located in Killarney, Ireland. This hands-on, site-based position is ideal for candidates with a strong CQV background and proven field experience on large GMP projects. Responsibilities include executing protocols, leading field meetings, and collaborating with cross-functional teams. The role offers an initial contract of 6 to 12+ months, focused on a state-of-the-art sterile fill-finish facility. #J-18808-Ljbffr
CSV Engineer - Limerick, Ireland - 12+ Month Contract I am currently looking for an experienced CSV Engineer who is interested in working for one of the leading companies in the Biopharmaceutical sector. This is a fantastic opportunity to join a hard-working team and work on a long term project in the pharma sector. Location: Limerick, Ireland Positions Available: 1 Type: Contract (12+ Months) Responsibilities Develop and execute validation strategies for GxP computerized systems, including manufacturing automation, laboratory instrumentation, and enterprise applications. Ensure compliance with Data Integrity (DI) requirements and regulatory guidelines (FDA, EMA, HPRA, MHRA). Author, review, and approve CSV documentation, including Validation Plans, URS, FS, DS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Reports. Perform gap assessments and remediation of data integrity issues for existing automation and control systems. Validate automation systems such as SCADA, DCS, BMS, MES, and PLC-based controls in accordance with GAMP 5. Support change control processes, deviations, and CAPAs related to computerized systems. Conduct periodic reviews and revalidations of systems to ensure ongoing compliance. Collaborate with IT and Automation teams to implement and maintain cybersecurity measures for validated systems. Participate in regulatory audits and inspections, providing validation evidence and support. Develop and deliver training for internal teams on CSV and Data Integrity principles. Support the integration of Industry 4.0/5.0 concepts, AI-driven automation, and digital transformation strategies. Requirements Bachelor’s or Master’s degree in Engineering, Computer Science, Life Sciences, or a related field. 5+ years of experience in Computer System Validation within the pharmaceutical, biotech, or medical device industry. Strong knowledge of GAMP 5, 21 CFR Part 11, Annex 11, and data integrity principles. Experience with automation systems such as SCADA, DCS, BMS, MES, and PLC controls. Hands-on experience with validation of laboratory and enterprise systems (LIMS, Empower, SAP, Trackwise, LabWare). Proficiency in writing validation documentation and executing validation test scripts. #J-18808-Ljbffr
A leading pharmaceutical firm is seeking an experienced CQV Lead for a major project in Munster, Ireland. The role involves overseeing HVAC and cleanroom work from construction to qualification in a fast-paced environment. Candidates must have proven experience in CQV HVAC, a strong field execution background, and familiarity with GMP regulations. The position is site-based and offers a dynamic working atmosphere, crucial for the completion of highly demanding tasks. #J-18808-Ljbffr
CQV Lead (HVAC / Cleanroom) – Kerry, Ireland (Pharma Project) Location: Kerry, Ireland Start Date: ASAP Contract Length: 12 months The Opportunity I’m supporting a major pharmaceutical project in Ireland and seeking an experienced CQV HVAC / Cleanroom Lead to take ownership of this workstream. This is a hands‑on, site‑based lead role, driving HVAC and cleanroom scope from construction through commissioning and qualification within a fast‑paced project environment. Responsibilities Lead HVAC & Cleanroom scope from construction through C&Q Oversee start-up, energization, shakedown & OV testing with vendors P&ID & W3 walkdowns with construction Vendor management during construction & SAT execution Drive field execution, troubleshooting & deviation closure Lead whiteboard meetings and coordinate across disciplines Requirements Proven experience as a CQV HVAC / Cleanroom Workstream Lead Strong hands‑on field execution background Experience within GMP environments (Annex 1/15, 21 CFR 210/211) Familiar with LOTO, PSSR, CSD/TTOP review Comfortable in fast‑paced, client‑facing environments jherod@optimussearch.com #J-18808-Ljbffr
