Sr. Quality Assurance and CSV Engineer
The Planet Group
Job Description
Sr. Engineer, Digital Systems Quality Assurance
\nLocation: Bridgewater, NJ | Hybrid
\nDuration: 12-month contract
\n \nWe are seeking a Senior Digital Systems Quality Assurance / CSV professional with strong experience supporting GxP computerized systems in pharmaceutical or biotechnology environments . The ideal candidate will have hands-on experience with computer system validation, clinical/enterprise platforms, and AI/ML-enabled GxP systems .
\n \nKey Responsibilities:
\n- \n
- Lead/support end-to-end Computer System Validation (CSV) activities. \n
- Create/review Validation Plans, URS, IQ/OQ/PQ, RTM, and Validation Summary Reports . \n
- Apply FDA CSA, GAMP 5, 21 CFR Part 11, and EU Annex 11 requirements. \n
- Support validation of Veeva Vault, clinical systems, laboratory systems, and other GxP platforms . \n
- Manage Change Control, periodic reviews, revalidation, CAPA, deviations, and inspection readiness . \n
- Support validation and quality oversight for AI/ML-enabled GxP systems . \n
- Support AI/ML controls including model testing, data integrity, drift monitoring, HITL oversight, and risk-based acceptance criteria . \n
- Support vendor/supplier qualification and regulatory inspection readiness. \n
Required Skills:
\n- \n
- 7+ years of GxP CSV/Computerized System Validation experience within pharma/biotech. \n
- Strong knowledge of 21 CFR Part 11, EU Annex 11, FDA CSA, ISPE GAMP 5, and ALCOA+ . \n
- Experience with Veeva Vault QMS/RIM/MedComms, ServiceNow, Qlik, or Entra ID preferred. \n
- Experience with clinical systems such as EDC, IRT, eTMF, CTMS and/or LIMS, CDS, ELN . \n
- Experience or strong knowledge of AI/ML validation in regulated/GxP environments . \n
- Bachelor's degree in Life Sciences, Computer Science, Engineering, or related field . \n
Vacancy posted 4 days ago
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