Engineer II, Facilities
$125,000–$165,000 year
On-siteWaltham, Massachusetts, United States
Job Summary
Troubleshoot equipment and utility systems using root cause analysis, work order management, and continuous improvement initiatives within highly regulated GMP environments. Manage quality systems including change controls, CAPAs, and deviations while leading technical writing for standard operating procedures and engineering specifications. Support engineering lifecycle processes for HVAC, steam, water, and gas utilities through commissioning, validation, and asset management in the CMMS. Lead walk-downs of engineering drawings and perform commissioning tests for base building infrastructure and utility systems. Collaborate cross-functionally with Facilities, Validation, and Quality teams to optimize operational excellence and mitigate safety risks.
Required Qualifications
- BS Degree in Mechanical, Chemical, Facilities, Industrial Engineering or equivalent
- 5+ years' experience in GMP biotech or FDA regulated environment
- Organized, independent, and collaborative
- Strong interpersonal, technical writing, and verbal communication skills
- Experience presenting and defending Facilities Engineering in Regulatory Audits
- Ability to stand, walk, bend and stretch for extended period of time
- Ability to lift 25-50 lbs
- Ability to push, pull, bend, kneel, twist and climb step ladders while wearing PPE
- Ability to perform routine repetitive motions with use of arms, wrists and hands
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