More jobs:
Validation Engineer
Job in
Newark, Essex County, New Jersey, 07175, USA
Listed on 2026-07-24
Listing for:
United Pharma
Full Time
position Listed on 2026-07-24
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering -
Pharmaceutical
Pharma Engineer, Quality Engineering
Job Description & How to Apply Below
We are seeking a Validation Engineer to support Computer System Validation (CSV) and Commissioning, Qualification & Validation (CQV) activities for pharmaceutical and biotechnology projects. This role involves validation documentation, system qualification, and ensuring compliance with GMP, GxP, and FDA regulations.
Key Responsibilities:
- Support CSV and CQV activities throughout the validation lifecycle.
- Prepare and execute IQ/OQ/PQ protocols for computerized systems, equipment, and laboratory instruments.
- Review URS, Functional Specifications (FS), and Design Specifications (DS).
- Develop validation plans, traceability matrices, protocols, and summary reports.
- Participate in risk assessments, change controls, deviations, CAPA, and data integrity initiatives.
- Collaborate with QA, IT, Engineering, Manufacturing, and Validation teams to ensure regulatory compliance.
Qualifications:
- Bachelor's degree in Engineering, Computer Science, Biotechnology, Life Sciences, Pharmacy, or related field.
- 0–3 years of experience in CSV, CQV, Validation, or regulated pharmaceutical/biotech environments.
- Knowledge of IQ/OQ/PQ, GMP, GxP, FDA regulations, and 21 CFR Part 11.
- Strong technical writing, analytical, and communication skills.
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