Senior CSV Manager – GxP Systems & Validation
Planet Pharma
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Job summary
Planet Pharma seeks a Senior Manager Computer System Validation (CSV) to lead risk-based validation across GxP systems in pharmaceutical/biotech operations. You will partner with IS Quality, QA, business owners, and vendors to plan, execute, and document validation activities for new implementations and changes.
Required: 10+ years of GxP CSV experience, strong knowledge of 21 CFR Part 11/EU Annex 11, and expertise in cloud-based SaaS validation.
Qualifications
- Bachelor's degree in Engineering, Life Sciences, Computer Science, or related field.
- 10+ years of GxP CSV experience in pharmaceutical or biotechnology environments, with hands-on project delivery.
- Strong knowledge of GxP requirements, 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity principles.
- Apply risk-based CSV methods and software lifecycle knowledge across the system lifecycle.
- Experience authoring and reviewing validation documentation, testing, discrepancies, and remediation.
- Experience validating cloud-based SaaS systems and evaluating vendor documentation.
- Experience with study-level electronic systems (EDC, IRT, PV databases).
- Ability to lead multiple complex validation projects with minimal supervision.
- Experience supporting audits or regulatory inspections and strong communication.
Responsibilities
- Define and execute risk-based validation approaches with IS Quality and stakeholders.
- Assess GxP impact, classify system risk, and evaluate ERES requirements.
- Author, review, and assess validation deliverables per 21 CFR Part 11 / EU Annex 11.
- Execute or coordinate validation testing and maintain traceability across docs.
- Validate cloud-based SaaS systems and evaluate vendor documentation.
- Define acceptance criteria, data integrity controls, and monitoring plans.
- Prepare system change requests and assess validation impact of upgrades.
- Organize validation records for efficient retrieval and review.
- Author and revise CSV procedures, forms, and templates.
Skills
Education
Tools
Job description
Planet Pharma seeks a Senior Manager Computer System Validation (CSV) to lead risk-based validation across GxP systems in pharmaceutical/biotech operations. You will partner with IS Quality, QA, business owners, and vendors to plan, execute, and document validation activities for new implementations and changes.
Required: 10+ years of GxP CSV experience, strong knowledge of 21 CFR Part 11/EU Annex 11, and expertise in cloud-based SaaS validation.
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