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.
Sr. Quality Assurance and CSV Engineer in Bridgewater at The Planet Group
This position is listed as contract and hybrid. It was posted yesterday.