CSV Validation Consultant, Life Sciences
Overview
You will own computer system validation for regulated life sciences environments, ensuring compliance with GxP and 21 CFR Part 11. You will work with cross-functional teams to validate ERP, LIMS, and MES systems. This role offers direct client exposure and the chance to shape validation strategies across multiple sites.
What You'll Do7
- 1Develop and execute validation protocols (IQ, OQ, PQ) for GxP systems in the first 90 days.
- 2Author and review validation deliverables including URS, FS, DS, and Traceability Matrix.
- 3Lead risk-based assessments for computerized systems, applying GAMP 5 principles.
- 4Coordinate with vendors and internal teams to ensure audit trail and data integrity compliance.
- 5Execute test scripts and document deviations, working with developers to resolve issues.
- 6Support regulatory inspections and internal audits by presenting validation evidence.
- 7Maintain validation status across system changes, reviewing change controls and impact assessments.
Requirements6
- 15+ years in computer system validation within life sciences or pharma.
- 2Hands-on experience with GxP, 21 CFR Part 11, GAMP 5, and Data Integrity.
- 3Proficiency in validating ERP, LIMS, or MES systems.
- 4Bachelor's degree in a scientific or IT-related field.
- 5Strong documentation skills with attention to regulatory detail.
- 6Ability to travel to client sites up to 25%.
Salary Insight
Salary not disclosed in listing
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