CQV/Validation Engineer
Job in
Los Angeles, Los Angeles County, California, 90079, USA
Listed on 2026-01-25
Listing for:
Intellectt Inc
Full Time
position Listed on 2026-01-25
Job specializations:
-
Engineering
Pharma Engineer, Biomedical Engineer, Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
We are seeking a CQV / Validation Engineer to support commissioning, qualification, and validation activities for pharmaceutical manufacturing systems, equipment, and utilities in a GMP-regulated environment. This role will ensure compliance with FDA, cGMP, and global regulatory requirements throughout the system and process lifecycle.
Responsibilities- Develop and execute DQ, IQ, OQ, and PQ protocols for manufacturing equipment, clean rooms, and GMP utilities (HVAC, WFI, PW, compressed air)
- Support process validation, cleaning validation, and computerized system validation (CSV) activities
- Ensure compliance with FDA 21 CFR Parts 210/211, 21 CFR Part 11, and EU GMP requirements
- Support deviations, CAPA, and change control related to validation activities
- Support internal and regulatory audits and maintain validation master plans (VMPs) and validation documentation
- Collaborate with Engineering, QA, Manufacturing, and IT teams during project and lifecycle phases
- Bachelor’s degree in Engineering, Life Sciences, or related field
- 3–7+ years of CQV/Validation experience in pharmaceutical or GMP-regulated environments
- Strong knowledge of cGMP, GAMP 5, FDA, and EU GMP requirements
- Experience with validation documentation systems and electronic quality systems
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