Position Summary
The Facility Engineer is responsible for the design, operation, maintenance, and continuous improvement of facility systems supporting GMP manufacturing operations. This role ensures that critical utilities, building systems, and equipment operate reliably and in compliance with regulatory and quality standards, supporting uninterrupted production in a highly regulated environment.
Key Responsibilities
- Manage and maintain critical facility systems including HVAC, purified water, WFI, clean steam, compressed air, and process gases
- Support commissioning, qualification, and validation (CQV) activities for new and existing facility equipment and systems
- Troubleshoot mechanical, electrical, and control system issues affecting cleanrooms and production areas
- Ensure facility systems remain in compliance with cGMP, FDA, and other applicable regulatory requirements
- Partner with Quality, EHS, and Manufacturing teams on deviations, CAPAs, and change controls related to facility systems
- Develop and maintain preventive maintenance programs for facility equipment
- Support facility expansion, retrofit, and capital improvement projects
- Review and update SOPs, drawings, and documentation related to facility operations
- Participate in risk assessments and support audits (internal and regulatory)
- Monitor energy usage and recommend efficiency improvements
Qualifications
- Bachelor's degree in Mechanical, Electrical, Chemical, or Facilities Engineering (or related field)
- 3+ years of experience in facilities engineering within a GMP-regulated environment (pharma, biotech, or medical device)
- Working knowledge of cleanroom classifications, HVAC systems, and critical utility systems
- Familiarity with FDA, EMA, and ISO regulatory frameworks
- Experience with CQV protocols and documentation
- Strong troubleshooting and root cause analysis skills
- Proficiency with CMMS platforms (e.g., Maximo, SAP PM) preferred
- Excellent communication skills for cross-functional collaboration
Preferred Experience
- Experience supporting facility expansions or new site startups
- Knowledge of building automation systems (BAS) and PLCs
- Six Sigma or Lean manufacturing exposure
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