Sr. Quality Assurance and CSV Engineer

Full-time

The Planet Group

Sr. Engineer, Digital Systems Quality Assurance

Location: Bridgewater, NJ | Hybrid

Duration: 12-month contract

We 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 .

Key Responsibilities:

Lead/support end-to-end Computer System Validation (CSV) activities.
Create/review Validation Plans, URS, IQ/OQ/PQ, RTM, and Validation Summary Reports .
Apply FDA CSA, GAMP 5, 21 CFR Part 11, and EU Annex 11 requirements.
Support validation of Veeva Vault, clinical systems, laboratory systems, and other GxP platforms .
Manage Change Control, periodic reviews, revalidation, CAPA, deviations, and inspection readiness .
Support validation and quality oversight for AI/ML-enabled GxP systems .
Support AI/ML controls including model testing, data integrity, drift monitoring, HITL oversight, and risk-based acceptance criteria .
Support vendor/supplier qualification and regulatory inspection readiness.

Required Skills:

7+ years of GxP CSV/Computerized System Validation experience within pharma/biotech.
Strong knowledge of 21 CFR Part 11, EU Annex 11, FDA CSA, ISPE GAMP 5, and ALCOA+ .
Experience with Veeva Vault QMS/RIM/MedComms, ServiceNow, Qlik, or Entra ID preferred.
Experience with clinical systems such as EDC, IRT, eTMF, CTMS and/or LIMS, CDS, ELN .
Experience or strong knowledge of AI/ML validation in regulated/GxP environments .
Bachelor's degree in Life Sciences, Computer Science, Engineering, or related field .

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Vacancy posted 13 hours ago

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