Remote CSV Validation Specialist — GxP & 21 CFR 11 Expert

Somewhere; United States; Remote; USD 120,000 - 170,000; Part time

Job summary

Somewhere is seeking a Software Validation Specialist to plan, execute, and document commissioning, qualification, and CSV activities across GxP systems, laboratory and manufacturing environments. This role operates in a regulated environment, ensuring systems and software remain validated and compliant with 21 CFR Part 11 and data integrity standards.

You will work independently and with SMEs, QA, IT, and manufacturing teams to develop validation requirements, author audit-ready documentation,

Qualifications

• Bachelor’s degree in engineering, computer science, life sciences, or related technical discipline.
• 5+ years of experience in equipment qualification and validation in pharma/biopharma/medical devices.
• 3+ years of hands-on experience in Computer System Validation (CSV).
• Experience validating GAMP Category 4 (configured) and Category 5 (custom) software using GAMP 5 principles.

Responsibilities

• Develop validation strategies aligned with ISPE Baseline Guide (C&Q, 2nd Edition), FDA expectations, and internal policies.
• Contribute to Validation Master Plans (VMPs), project validation plans, SOPs, and lifecycle documentation.
• Participate in system impact assessments and classification of equipment and computerized systems.
• Plan, author, review, and execute CSV activities for GxP systems including IQ/OQ/PQ and traceability.
• Develop and maintain lifecycle documentation (Validation Plans, Risk Assessments, protocols).
• Ensure audit-ready qualification and CSV documentation and manage deviations and change control.

Skills

Regulatory knowledge

Problem solving

Project management

Test automation / CSV tools

Education

Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related technical discipline

Job description

Somewhere is seeking a Software Validation Specialist to plan, execute, and document commissioning, qualification, and CSV activities across GxP systems, laboratory and manufacturing environments. This role operates in a regulated environment, ensuring systems and software remain validated and compliant with 21 CFR Part 11 and data integrity standards.

You will work independently and with SMEs, QA, IT, and manufacturing teams to develop validation requirements, author audit-ready documentation,