Pharma CSV Lead: Validation Expert in GxP Systems

Katalyst-Healthcares-; Fayetteville (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

JobDiva, Inc. seeks a seasoned professional to lead validation efforts in the pharmaceutical, biotech, or medical device space. The role requires 2+ years in SDLC and 3+ years in CSV, with strong knowledge of FDA guidance and GxP standards.

You will draft and review validation deliverables from requirements through validation reports and collaborate with remote teams on multiple projects to ensure compliance and quality.

Qualifications

• 2+ years in the System Development Lifecycle (SDLC).
• 3+ years in Computer System Validation (CSV).
• Experience with FDA guidance and GxP standards.
• Ability to draft and review validation deliverables from requirements to validation reports.
• Coordinate with remote teams on validation projects.

Responsibilities

• Lead validation efforts across applied pharmaceutical, biotech, or medical device programs.
• Draft, review and approve validation deliverables (requirements, test plans, validation protocols, and reports).
• Collaborate with global/remote teams to ensure compliance with FDA and GxP requirements.
• Oversee evidence generation and traceability throughout the System Development Lifecycle.

Skills

SDLC

CSV

FDA guidance

GxP

Requirements

Validation reports

Remote work

Job description

JobDiva, Inc. seeks a seasoned professional to lead validation efforts in the pharmaceutical, biotech, or medical device space. The role requires 2+ years in SDLC and 3+ years in CSV, with strong knowledge of FDA guidance and GxP standards.

You will draft and review validation deliverables from requirements through validation reports and collaborate with remote teams on multiple projects to ensure compliance and quality.