We are seeking a high-accountability Utilities Engineer to join our Facilities & Engineering (F&E) group within the biopharmaceutical industry. As a designated System Owner, you will be the technical lead for critical utility systems, ensuring they are safe, compliant, and optimized for peak performance.
This is a hands-on, independent contract role for an engineer who thrives on technical ownership and inspection readiness.
Key Responsibilities
System Ownership & Reliability
- Performance: Monitor and optimize day-to-day performance, uptime, and reliability for assigned systems.
- Maintenance: Manage vendors, oversee preventive/predictive maintenance strategies, and execute CMMS work orders.
- Troubleshooting: Lead data-driven root cause analysis (RCA) and implement practical technical resolutions.
- Infrastructure: Maintain oversight of critical spares and manage the interface between utility assets and site BMS/PCS automation systems.
Quality, Compliance & Safety
- Quality Management: Lead deviations, non-conformances, and CAPAs from inception to closure.
- Audit Readiness: Act as the Subject Matter Expert (SME) during regulatory inspections and maintain a permanent "inspection-ready" state.
- Documentation: Review and approve SOPs, change controls, and design reviews for equipment upgrades.
Project & Cross-Functional Support
- Collaboration: Act as the technical liaison for Manufacturing, QA, and EHS.
- Upgrades: Support capital projects and site expansions by contributing to FAT, SAT, and IOQ deliverables.
Candidate Profile
Essential Experience:
- Education: Bachelor's degree in Mechanical, Electrical, or Chemical Engineering.
- Industry: Proven track record in a GMP-regulated pharmaceutical or biotech environment.
- Technical Depth: Extensive experience operating/troubleshooting HVAC, WFI, and clean/process utilities.
- Quality Systems: Solid experience handling deviations and root cause analysis.
Preferred Skills:
- Prior experience as a designated System Owner or SME.
- Direct involvement in regulatory audits and site inspections.
- Strong understanding of automation (BMS/PCS) and GMP qualification protocols.
