Utilities Engineer

Denali Therapeutics•Salt Lake City, UT

About The Position

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. This role leads utility system performance, reliability, and lifecycle management to support GMP manufacturing operations. Responsibilities include ensuring compliance of critical utilities (e.g., WFI, clean steam, HVAC, compressed gases), managing change control, maintaining system documentation, supporting maintenance and repairs, conducting periodic system reviews, minimizing downtime through reliability strategies, coordinating site infrastructure upgrades, revising utility P&IDs, conducting risk assessments, and training teams to support continuous improvement across facility operations.

Requirements

Bachelor’s degree in mechanical engineering, electrical engineering or a related technical discipline and 7+ years of related experience (or Master’s degree and 4+ years of related experience)
Hands-on experience with critical utility systems (e.g., WFI, clean steam, HVAC, building automation systems, compressed gases)
Experience with commissioning, qualification, and 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 experience collaborating within technical and cross-functional teams, building trustful and effective relationships with authenticity and humility, influencing, partnering and collaborating across all levels
Confidence to lead through uncertainty and in a rapidly changing environment
Ability to contribute to a team with shared purpose and vision; foster a “One Denali” environment
Strong self-awareness of communication style and impact on others
Exceptional influencing, partnership, and collaboration skills across all levels
Excellent oral presentation and written communication skills
Physical requirements – must be able to wear specialized gowning, lift and manipulate items over 25lbs, climb ladders, and stand for extended periods

Nice To Haves

Biopharmaceutical or GMP-regulated industry experience preferred

Responsibilities

Lead lifecycle management of GMP utility systems, including specification, procurement, installation, commissioning, and qualification (CQV) in compliance with FDA GMP requirements.
Manage Change Control for utility systems, ensuring appropriate impact assessments, documentation, and timely implementation.
Maintain accurate utility system master data, including specifications, capacities, and operating parameters for compliance and audit readiness.
Monitor and optimize performance of critical utilities (WFI, clean steam, HVAC, compressed air, nitrogen), ensuring operation within validated ranges.
Support maintenance and repair activities, including troubleshooting system issues 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, including performance trending, capacity evaluations, and 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, and provide training to drive continuous improvement.