Validation Engineer
Job in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2026-08-14
Listing for:
Novyra Life Sciences
Full Time
position Listed on 2026-08-14
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist -
Engineering
Pharma Engineer, Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
We are seeking experienced CQV Validation Engineers to support a major pharmaceutical/cell therapy client in Boston.
KeyResponsibilities & Requirements:
- Execute qualification of utilities, process equipment, facilities, and analytical systems
- Perform validation activities within GMP-regulated manufacturing environments
- Support aseptic processing, APS, EMPQ, and airflow studies
- Work with BMS, EMS, SCADA, and CMMS systems
- Develop and execute CQV lifecycle documentation, including URS, FS, SRS/HDS, FAT, SAT, protocols, and reports
- Perform impact assessments and support equipment/facility design from a validation perspective
- Ensure compliance with 21 CFR Parts 210, 211 & 11, ISO standards, USP, GAMP 5, ISPE CQV, EU GMP Annex 1/11/15, and applicable ATMP guidelines
- Collaborate with Engineering, Quality, Manufacturing, and other cross-functional teams
- Prepare clear, regulatory-ready GMP documentation
- Pharmaceutical, biotechnology, cell therapy, or regulated manufacturing experience
- GMP facility, plant, process, or site engineering experience
- Strong knowledge of CQV/Validation practices
- Experience with CMMS, EDMS, MES, LIMS, EMS, and/or SCADA
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