Remote GxP Validation Lead: CSV & CQV Expert

Somewhere; United States; Remote; USD 110,000 - 165,000; Full time

Job summary

Somewhere is seeking a GxP Validation Engineer to join ourQuality/Validation team. This remote role focuses on validating GxP systems, equipment, utilities, and processes across the lifecycle while maintaining audit-ready documentation.

You will work with SMEs, QA, IT, Engineering, Manufacturing, Laboratory, and Facilities to define requirements and drive validation through completion.

Qualifications

• Bachelor's degree in engineering, computer science, life science, or related field.
• 5+ years of equipment qualification and validation experience in pharma/biopharma/medical device.
• 3+ years of Computer System Validation experience.
• Hands-on validation across CQV, CSV, temperature mapping, and manufacturing equipment.
• Experience validating GAMP 5 Category 4 and 5 software systems.
• Knowledge of 21 CFR Part 11 and ERES.
• Strong documentation and audit-ready deliverables.

Responsibilities

• Develop and implement validation strategies aligned with ISPE C&Q Baseline Guide and FDA expectations.
• Create and maintain Validation Master Plans, SOPs, and risk assessments.
• Execute CQV activities: DR, DQ, IQ, OQ, PQ; perform temperature mapping.
• Plan and execute CSV for GxP systems and maintain lifecycle docs.
• Ensure data integrity (ALCOA+) and audit readiness.

Skills

GxP validation

Technical writing

Cross-functional collaboration

Audit readiness

Education

Bachelor's degree in engineering, computer science, life science

Job description

Somewhere is seeking a GxP Validation Engineer to join ourQuality/Validation team. This remote role focuses on validating GxP systems, equipment, utilities, and processes across the lifecycle while maintaining audit-ready documentation.

You will work with SMEs, QA, IT, Engineering, Manufacturing, Laboratory, and Facilities to define requirements and drive validation through completion.