Role Summary
Senior Engineer, Utility – Based in Durham, NC. Lead reliability and efficiency of essential utility systems powering life-changing therapies. Drive projects, collaborate cross-functionally, and support continuous improvement to maintain compliance and operational excellence.
Responsibilities
- System ownership for site-based utility, electrical, and HVAC systems (including water-for-injection, water pre-treatment, chillers, boilers, compressed gases, plant steam/condensate, wastewater, biowaste inactivation, air handling units, cold rooms, switchgear, emergency generators, cooling towers, fire protection, and control systems).
- Oversee installation, maintenance, troubleshooting, and repair of critical facility and utility assets to ensure reliability and minimize downtime.
- Manage equipment changes and upgrades to maintain validated states, ensuring compliance with qualification and regulatory requirements.
- Create, review, and approve essential documentation including SOPs, engineering drawings, maintenance plans, and equipment specifications to support robust operations.
- Investigate non-conformance events and alarm issues, applying root cause analysis and developing effective engineering solutions to prevent recurrence.
- Drive operational excellence initiatives, implementing strategies to optimize system reliability, reduce failure modes, and improve energy efficiency.
- Provide SME-level leadership on projects, guiding all phases from concept through closeout, ensuring timely delivery and adherence to quality standards.
- Collaborate with cross-functional teams including operations, quality, and manufacturing sciences to achieve site objectives and support new product introductions.
- Mentor and coach junior engineers, fostering technical growth and promoting best practices across the engineering team.
Qualifications
- Required:
- B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, with a minimum of 8 years' experience in maintenance, automation, or engineering support within pharmaceutical/biotech sectors.
- Strong technical writing skills and ability to create clear, compliant documentation.
- Proven troubleshooting expertise for complex equipment and root cause analysis.
- Hands-on experience with automated building management systems and industrial PLCs.
- Ability to lead projects from initiation through completion, ensuring compliance and timely delivery.
- Excellent communication and collaboration skills in cross-functional teams.
- Preferred:
- Associate's degree/Diploma/Certification in Engineering Technology or related skilled technical field with 10+ years of relevant experience, or equivalent 12+ years in the pharmaceutical/biotech industry.
Skills
- Technical writing
- Root cause analysis
- Automated building management systems
- Industrial PLCs
- Project leadership
- Cross-functional collaboration
Education
- B.S. in Chemical, Electrical, or Mechanical Engineering (or related field) or equivalent experience as specified above.
Additional Requirements
- Travel requirements not specified.
- Visa sponsorship not available for this position.