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Validation Engineer
Job in
New Bedford, Bristol County, Massachusetts, 02746, USA
Listed on 2026-07-06
Listing for:
United Pharma
Full Time
position Listed on 2026-07-06
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Responsibilities
- Manage qualification and lifecycle activities for QC laboratory instruments and software systems
- Author and execute URS, DQ, IQ/OQ protocols, validation plans, risk assessments, and summary reports
- Perform Computer System Validation (CSV) activities and software testing
- Support change controls, deviations, investigations, and CAPA implementation
- Maintain asset management records, calibration schedules, and preventive maintenance activities
- Coordinate with vendors for installation, qualification, and troubleshooting activities
- Bachelor's or Master's degree in Engineering, Biology, Chemistry, or related field
- 2–4+ years of Validation, CSV, or laboratory systems experience in a GMP environment
- Strong knowledge of cGMP, 21 CFR Part 11, GAMP, Data Integrity, and Electronic Records requirements
- Experience with change controls, deviations, investigations, and quality systems
- Familiarity with laboratory instruments, computerized systems, and validation documentation
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