Sr. Quality Assurance and CSV Engineer

The Planet Group; Bridgewater Township (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

The Planet Group is seeking a Senior Digital Systems Quality Assurance professional to lead end‑to‑end CSV activities for GxP systems in pharma/biotech environments. Strong emphasis on validation planning, IQ/OQ/PQ, and regulatory alignment.

Ideal candidates will have hands‑on experience with AI/ML‑enabled GxP systems, data integrity practices, drift monitoring, and HITL oversight, ensuring inspection readiness and robust change control.

Qualifications

• 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.

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.

Skills

GxP CSV/Computerized System Validation

Regulatory compliance (FDA CSA, EU)

AI/ML validation in regulated env

Clinical systems: EDC/IRt/eTMF/CTMS

Veeva Vault QMS/RIM/MedComms

ServiceNow/Qlik/Entra ID

Tools

Veeva Vault QMS/RIM/MedCommS

ServiceNow

Qlik

Entra ID

Job description

Sr. Engineer, Digital Systems Quality Assurance

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.