Project Engineer, Validation Engineer
Job in
Cambridge, Middlesex County, Massachusetts, 02140, USA
Listed on 2026-06-14
Listing for:
Novozen Healthcare LLC
Full Time
position Listed on 2026-06-14
Job specializations:
-
Engineering
Validation Engineer, Manufacturing Engineer, Pharma Engineer, Quality Engineering
Job Description & How to Apply Below
Job Title:
Project/Site Engineer — GxP Manufacturing
Employment Type:
W2/1099
Duration: 1 Year
Job Summary:
We’re seeking a Project/Site Engineer with GMP pharma/biotech experience to support manufacturing systems, CQV activities, change controls, deviations/CAPAs, and GMP documentation in a regulated environment. Experience with BMS, EMS, SCADA, and validation activities preferred.
Responsibilities- Provide engineering support for GMP manufacturing, facilities, and utilities
- Support change controls, deviations, CAPAs, and GMP documentation
- Assist with CQV activities including FAT/SAT, IQ/OQ/PQ
- Review P&IDs, specifications, redlines, and engineering documents
- Support audit readiness and regulatory inspections
- Troubleshoot manufacturing systems and equipment
- Coordinate with vendors, contractors, and internal teams
- Bachelor’s degree in Engineering or related field
- 4+ years of GMP pharma/biotech manufacturing experience
- Experience with CQV documentation and change controls
- Knowledge of BMS, EMS, SCADA, and CMMS systems
- Familiarity with ISO cleanroom environments
- Strong GMP documentation and compliance experience
- Cell & Gene Therapy or aseptic manufacturing experience
- Experience with Kneat, Val Genesis, GAMP, or 21 CFR Part 11
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