
Clean Utilities Engineer
- Pirbright, Surrey
- Permanent
- Full-time
- Deviations/CAPA: Initiates deviations in Quality electronic systems when Engineering and Maintenance non-conformances are detected
- System Oversight: Manage the operation, maintenance, and performance of clean utility systems such as Purified Water (PW), Water for Injection (WFI), Clean Steam, Compressed Air, and Process Gases
- Compliance & Documentation: Ensure systems meet GMP, regulatory, and safety standards. Maintain SOPs, validation protocols, and change control documentation
- Troubleshooting & Reliability: Investigate system deviations or failures, perform root cause analysis, and implement corrective and preventive actions (CAPAs)
- Continuous Improvement: Identify and implement system upgrades or process improvements to enhance reliability, efficiency, and sustainability
- Audit Readiness: Act as Subject Matter Expert (SME) during internal and external audits, inspections, and regulatory reviews
- Degree in Mechanical, Chemical, or Process Engineering (or related field)
- 3+ years of experience in clean utilities within a GMP-regulated pharmaceutical or biotech environment
- Strong knowledge of clean utility systems (WFI, PW, Clean Steam, etc.) and associated regulatory requirements (e.g., EU GMP Annex 1, USP, ISPE Baseline Guides)
- Experience with validation, change control, and deviation management
- Excellent problem-solving, communication, and teamwork skills
- Excellent organizational, communication and man management skills
- Strong knowledge of Regulatory requirements, and quality control procedures
- Excellent problem-solving skills, attention to detail, and the ability to work independently and as part of a team
- Relevant certifications (e.g., Pharmaceutical GMP Professional) are a plus
- Knowledge of GMP regulations
- Leadership, strength of proposal and conviction
- Capable to innovate and to challenge the current processes, organizations
- Capable to adapt to an ever-changing environment and to manage his/her teams through change cycles
- Good IT skills (word, excel, power point, Visio etc.)