Engineer - F&E Environmental & Contamination Control
On-siteWest Greenwich, Rhode Island, United States
Job Summary
Lead deviation investigations and root cause analyses for equipment, utility, automation, and facility events, ensuring all documentation is technically accurate and inspection-ready. Manage end-to-end corrective and preventive actions while collaborating cross-functionally with manufacturing, quality, and engineering teams to drive operational reliability. Serve as a subject matter expert during regulatory inspections and audits, defending technical conclusions and supporting continuous improvement initiatives using data analytics and digital tools. Prioritize multiple investigations simultaneously in a dynamic manufacturing environment, maintaining strict adherence to site procedures and quality system requirements.
Required Qualifications
- High school diploma / GED and 8 years of Engineering, Facilities, Manufacturing, Automation, CQV, Quality, or related experience
- Associate's degree and 6 years of Engineering, Facilities, Manufacturing, Automation, CQV, Quality, or related experience
- Bachelor's degree and 2 years of Engineering, Facilities, Manufacturing, Automation, CQV, Quality, or related experience
- Master's degree
- BS/BA in Engineering, Life Sciences, Biotechnology, Chemistry, or related discipline
- 4+ years of experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments
- Experience with: Facilities & Engineering systems
- Experience with: Equipment troubleshooting
- Experience with: Utility systems
- Experience with: Automation systems (DeltaV, BAS, PI)
- Experience with: Commissioning & Qualification (C&Q)
- Experience with: Root Cause Analysis methodologies
- Experience with: Change Control and Quality Systems
- Strong technical writing and analytical problem-solving skills
- Ability to influence and lead cross-functional teams without direct authority
- Experience applying AI, analytics, or digital tools to support investigations and continuous improvement
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