The CQV Engineer will be responsible for leading and executing Commissioning, Qualification, and Validation (CQV) activities across manufacturing equipment, process systems, clean utilities, facilities, and automated systems. You will ensure all systems are designed, installed, tested, and maintained in strict compliance with current Good Manufacturing Practices (cGMP), local Irish requirements (HPRA), and international regulatory standards (EMA/FDA).
Key Responsibilities
Protocol Generation & Execution
- Author, review, and execute CQV lifecycle documentation, including User Requirement Specifications (URS), Commissioning Test Scripts, Installation/Operational/Performance Qualifications (IQ/OQ/PQ), and Summary Reports.
- Conduct risk-based assessments (such as FMEA/HAZOP) in accordance with ASTM E2500 and ICH Q9 guidelines.
- Lead and perform P&ID walk-downs, field verification, and system turnover reviews alongside engineering and construction teams.
Project & Field Execution
- Coordinate and oversee Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for incoming manufacturing equipment and utility modules.
- Support CQV lifecycle activities for critical systems, including API process equipment, bioprocess vessels, clean utilities (WFI, Purified Water, Clean Steam, Process Gases), HVAC systems, and temperature-controlled storage units.
- Interface with Automation Engineers to support Computerized Systems Validation (CSV) and PLC/SCADA/DCS interface qualification where necessary.
Quality, Compliance & Lifecycle Maintenance
- Investigate validation deviations and test failures, performing root-cause analysis and identifying suitable Corrective and Preventive Actions (CAPAs).
- Manage and execute Change Control activities related to equipment and utility modifications.
- Ensure all validation activities strictly adhere to Data Integrity principles (ALCOA+) and cGMP guidelines.
- Assist during internal quality audits and external regulatory agency inspections (HPRA, FDA, etc.).
Required Qualifications & Skills
Experience & Education
- Education: Bachelor's Degree (B.Sc / B.E.) in Chemical Engineering, Mechanical Engineering, Biotechnology, or a related science/engineering discipline.
- Experience: 3+ years of direct CQV experience within a cGMP regulated biopharmaceutical or pharmaceutical manufacturing environment.
- Proven track record delivering qualification packages for API process equipment, clean utilities, and automated systems.
Technical Knowledge
- In-depth knowledge of European (EMA/HPRA) and US (FDA) cGMP regulations, ISPE Good Practice Guides, ASTM E2500, and Annex 11 / 21 CFR Part 11 requirements.
- Strong technical background in utility systems (WFI, HVAC, Clean Steam) and process units (bioreactors, filtration, vessel skids).
- Experience with quality management systems (e.g., TrackWise, Veeva, or similar software).
Soft Skills
- Exceptional technical writing ability and clear, concise communication skills.
- Strong cross-functional collaboration skills, with the ability to build rapport across Quality Assurance, Automation, Operations, and external contractors.
- Excellent time management skills with a history of hitting key milestones within capital project schedules.
Preferred Qualifications
- Experience with DeltaV, SCADA, or automated batch processing environments.
- Lean Six Sigma certification or formal training in root-cause analysis methodologies (5 Whys, Fishbone).
- Experience participating in capital expansion projects or technology transfers.
