CSV Engineer
Job in
Toms River, Ocean County, New Jersey, 08757, USA
Listed on 2026-09-10
Listing for:
Intellectt INC
Full Time
position Listed on 2026-09-10
Job specializations:
-
IT/Tech
-
Quality Assurance - QA/QC
Job Description & How to Apply Below
Title: Computer System Validation (CSV) Engineer
Location: New Jersey
Duration: 6+ Months
Industry: Pharmaceutical
Employment Type: Contract
Payrate: $43 - $48/hr on W2
We are seeking an experienced Computer System Validation (CSV) Engineer to support validation activities for computerized systems within a GMP-regulated pharmaceutical environment. The ideal candidate will have strong hands-on experience with CSV lifecycle documentation, GAMP 5, 21 CFR Part 11, and GxP compliance.
Responsibilities- Develop and execute CSV documentation, including URS, Risk Assessments, IQ/OQ/PQ, Traceability Matrix, and Validation Summary Reports.
- Perform validation activities for GxP computerized systems and ensure systems remain in a validated state.
- Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, GMP, and Data Integrity requirements.
- Support Change Controls, Deviations, CAPA, periodic reviews, and audit activities.
- Collaborate with QA, IT, Engineering, Manufacturing, and cross-functional teams.
- Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.
- 4+ years of CSV experience in the Pharmaceutical or Biotech industry.
- Strong knowledge of GAMP 5, 21 CFR Part 11, GxP, and Data Integrity.
- Hands-on experience with CSV lifecycle documentation and IQ/OQ/PQ execution.
- Experience with systems such as LIMS, MES, SCADA, ERP, or QMS is preferred.
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