
Utilities Engineer
1 week ago
**About the Role**:
We are seeking a Senior Utilities Engineer to support the reliable operation, optimisation, and project delivery of utility systems within a GMP-compliant pharmaceutical or biopharmaceutical facility. The role requires strong hands-on experience with both black utilities (e.g., steam, HVAC, chilled water, compressed air) and clean utilities (e.g., WFI, PW, Clean Steam, process gases).
**Key Responsibilities**:
- Ensure the reliable and compliant operation of black and clean utility systems, supporting both daily operations and capital projects.
- Provide engineering support for troubleshooting, maintenance, and optimisation of utility systems across the site.
- Review and develop specifications, SOPs, and technical documentation related to utility systems.
- Support or lead commissioning, qualification, and validation (CQV) activities for utility systems (URS, FAT/SAT, IQ/OQ protocols).
- Participate in utility capacity planning and system upgrades to support new production needs or expansions.
- Collaborate with cross-functional teams (engineering, QA, manufacturing, validation, automation) to ensure system readiness and GMP compliance.
- Drive continuous improvement initiatives to improve utility system efficiency, reliability, and sustainability.
- Support investigations and change controls involving utility systems, ensuring timely and compliant resolution.
**Requirements**:
- Bachelor’s Degree in Mechanical, Chemical, or related Engineering discipline.
- Minimum 5+ years of experience in a GMP-regulated pharmaceutical/biopharmaceutical facility, with direct involvement in utilities engineering.
- Proven hands-on experience in both black utilities (e.g., boilers, chillers, HVAC, compressed air) and clean utilities (e.g., WFI, PW, Clean Steam, CDA, process gases).
- Familiar with CQV documentation and execution in a GMP context.
- Strong understanding of relevant regulatory and industry guidelines (e.g., ISPE, ASME BPE, EU GMP).
- Excellent problem-solving, communication, and cross-functional collaboration skills.
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