CSV Engineer

Comprehensive Resources INC; Plainfield (NJ); Hybrid; USD 110,000 - 150,000; Full time

Job summary

Comprehensive Resources INC is seeking a CSV Validation Consultant for the Pharma sector in Plainfield, NJ. This hybrid role requires extensive experience in computer system validation within the pharmaceutical/life sciences industry and a strong command of GxP, FDA Part 11, and data integrity.

You will prepare and review URS, FRS, risk assessments, IQ/OQ/PQ, and validation plans/reports, while supporting QA/Validation teams and audit readiness.

Qualifications

• Experience in Computer System Validation (CSV) within the Pharmaceutical/Life Sciences industry.
• Strong knowledge of GxP, FDA Part 11, GAMP 5, and data integrity requirements.
• Experience preparing URS, FRS, Risk Assessments, IQ/OQ/PQ, Validation Plans and Reports.
• Hands-on experience validating GxP computerized systems and related documentation.
• Knowledge of change control, deviation, CAPA, and SOPs.
• Experience working with QA/Validation teams and supporting audits/inspection readiness.
• Strong documentation and communication skills.

Responsibilities

• Validate GxP computerized systems and related documentation.
• Prepare IQ/OQ/PQ, Validation Plans and Reports.
• Manage change control, deviations, CAPA, and SOPs.
• Collaborate with QA/Validation teams and support audits/inspections.

Skills

CSV validation

GxP compliance

FDA Part 11

GAMP 5

Data integrity

Documentation

Audit readiness

Job description

Job Title: CSV Validation Consultant - Pharma

Location: Plainfield,NJ (Hybrid)
Experience: 10 years

Job Description:

• Experience in Computer System Validation (CSV) within the Pharmaceutical/Life Sciences industry.
• Strong knowledge of GxP, FDA 21 CFR Part 11, GAMP 5, and data integrity requirements.
• Experience preparing/reviewing URS, FRS, Risk Assessments, IQ/OQ/PQ, Validation Plans and Reports.
• Hands-on experience with validation of GxP computerized systems and related documentation.
• Knowledge of change control, deviation, CAPA, and SOPs.
• Experience working with QA/Validation teams and supporting audits/inspection readiness.
• Strong documentation and communication skills.

Email: [e-mail]