Sr. Quality Assurance and CSV Engineer

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 7 days ago

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