Sr. Engineer - F&E Environmental & Contamination Control
On-siteWest Greenwich, Rhode Island, United States
Job Summary
Lead deviation investigations and root cause analysis for equipment, utility, automation, and facility events, ensuring all findings are technically accurate and inspection-ready. Manage end-to-end corrective and preventive actions (CAPA) while collaborating with cross-functional teams to drive operational reliability and continuous improvement. Serve as a Subject Matter Expert during regulatory inspections, defending technical conclusions and supporting audit response development. Translate complex engineering data into concise documentation that meets Quality Management System requirements and prioritize multiple investigations simultaneously in a dynamic manufacturing environment.
Required Qualifications
- High school diploma / GED and 10 years of Engineering, Facilities, Manufacturing, Automation, CQV, Quality, or related experience
- Associate's degree and 8 years of Engineering, Facilities, Manufacturing, Automation, CQV, Quality, or related experience
- Bachelor's degree and 4 years of Engineering, Facilities, Manufacturing, Automation, CQV, Quality, or related experience
- Master's degree and 2 years of Engineering, Facilities, Manufacturing, Automation, CQV, Quality, or related experience
- Doctorate
- BS/BA in Engineering, Life Sciences, Biotechnology, Chemistry, or related discipline
- 5+ 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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