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Commissioning Engineer
Job in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2026-05-10
Listing for:
Technical Source
Full Time
position Listed on 2026-05-10
Job specializations:
-
Engineering
Pharma Engineer -
Quality Assurance - QA/QC
Job Description & How to Apply Below
Technical Source is seeking a mid-level Equipment Validation Engineer to support commissioning and qualification activities for a GMP-regulated biopharmaceutical manufacturing facility in the Boston area. This role is hands‑on and execution-focused, supporting equipment from installation through qualification to ensure compliance and startup readiness.
Key Responsibilities- Execute commissioning and qualification (C&Q) activities for GMP equipment
- Author, review, and redline validation documentation (URS, FRS, DDS)
- Develop and execute IQ/OQ protocols and summary reports
- Support commissioning documentation and system turnover
- Partner with Engineering, QA, and vendors to resolve issues during execution
- Support change control processes and validation updates
- Ensure all documentation aligns with cGMP and GDP standards
- Maintain validation lifecycle documentation per client and project requirements
- Bachelor’s degree in Engineering, Life Sciences, or related field
- 3+ years of experience in equipment qualification within GMP environments
- Hands‑on experience executing IQ/OQ protocols
- Strong understanding of:
- cGMP regulations
- Good Documentation Practices (GDP)
- FDA validation requirements
- Experience with change control systems
- Familiarity with 21 CFR Part 210, 211, and Part 11
- Ability to work onsite in a cross‑functional project environment
- Experience with parts washers and/or cleaning validation
- Exposure to a variety of biopharma manufacturing equipment
- Experience supporting commissioning (not just documentation)
- Background in fast‑paced or startup/expansion environments
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