Utilities Engineer
Denali Therapeutics
2 months ago
On-site
Salt Lake City, UT
Operations
Key Accountabilities / Core Job Responsibilities
- Lead lifecycle management of GMP utility systems (specification, procurement, installation, commissioning, qualification/CQV) in compliance with FDA GMP requirements.
- Manage Change Control for utility systems, including impact assessments, documentation, and timely implementation.
- Maintain accurate utility system master data (specifications, capacities, operating parameters) for compliance and audit readiness.
- Monitor and optimize performance of critical utilities (WFI, clean steam, HVAC, compressed air, nitrogen) within validated ranges.
- Support maintenance and repair activities, including troubleshooting and partnering with maintenance teams to restore operations.
- Develop and implement reliability and preventive maintenance strategies, including spare parts optimization to minimize downtime.
- Conduct periodic reviews of utility systems (performance trending, capacity evaluations, compliance checks).
- Coordinate facility and utility upgrades with internal teams and contractors, ensuring minimal disruption and GMP compliance.
- Revise and maintain P&IDs and engineering documentation; conduct risk assessments; support deviations/CAPAs; provide training for continuous improvement.
Qualifications / Skills
- Bachelor’s degree in mechanical engineering, electrical engineering, or related technical discipline with 7+ years of experience (or Master’s degree with 4+ years).
- Biopharmaceutical or GMP-regulated industry experience preferred.
- Hands-on experience with critical utility systems (WFI, clean steam, HVAC, building automation systems, compressed gases).
- Experience with commissioning/qualification/validation (CQV) of utility systems.
- Familiarity with regulatory expectations (FDA, EMA, ISPE Baseline Guides, ASME BPE).
- Ability to travel up to 10% by air and road.
- Demonstrated cross-functional collaboration and influencing skills.
- Confidence to lead through uncertainty; strong communication (oral and written).
- Physical requirements: wear specialized gowning, lift/manipulate items over 25 lbs, climb ladders, stand for extended periods.
Benefits
- Competitive total rewards package including 401k, healthcare coverage, and ESPP, plus other benefits.
- Lead lifecycle management of GMP utility systems (specification, procurement, installation, commissioning, qualification/CQV) in compliance with FDA GMP requirements.
- Manage Change Control for utility systems, including impact assessments, documentation, and timely implementation.
- Maintain accurate utility system master data (specifications, capacities, operating parameters) for compliance and audit readiness.
- Monitor and optimize performance of critical utilities (WFI, clean steam, HVAC, compressed air, nitrogen) within validated ranges.
- Support maintenance and repair activities, including troubleshooting and partnering with maintenance teams to restore operations.
- Develop and implement reliability and preventive maintenance strategies, including spare parts optimization to minimize downtime.
- Conduct periodic reviews of utility systems (performance trending, capacity evaluations, compliance checks).
- Coordinate facility and utility upgrades with internal teams and contractors, ensuring minimal disruption and GMP compliance.
- Revise and maintain P&IDs and engineering documentation; conduct risk assessments; support deviations/CAPAs; provide training for continuous improvement.
Qualifications / Skills
- Bachelor’s degree in mechanical engineering, electrical engineering, or related technical discipline with 7+ years of experience (or Master’s degree with 4+ years).
- Biopharmaceutical or GMP-regulated industry experience preferred.
- Hands-on experience with critical utility systems (WFI, clean steam, HVAC, building automation systems, compressed gases).
- Experience with commissioning/qualification/validation (CQV) of utility systems.
- Familiarity with regulatory expectations (FDA, EMA, ISPE Baseline Guides, ASME BPE).
- Ability to travel up to 10% by air and road.
- Demonstrated cross-functional collaboration and influencing skills.
- Confidence to lead through uncertainty; strong communication (oral and written).
- Physical requirements: wear specialized gowning, lift/manipulate items over 25 lbs, climb ladders, stand for extended periods.
Benefits
- Competitive total rewards package including 401k, healthcare coverage, and ESPP, plus other benefits.