JOB SUMMARY

The CSV Engineer is responsible for planning, executing, and documenting validation activities for GxP-regulated computerized systems, ensuring compliance with relevant regulatory requirements and data integrity standards. The CSV Engineer collaborates with Quality, IT, Engineering, and business teams to support the full lifecycle of system implementations and upgrades, including laboratory, manufacturing, and enterprise systems.

MAIN RESPONSIBILITIES

• Develop and execute risk-based validation strategies and deliverables for computerized systems in compliance with GxP, 21 CFR Part 11, EU Annex 11, and data integrity requirements.
• Author and review validation documentation, including Validation Master Plans, User Requirements Specifications (URS), Functional/Design Specifications, Risk Assessments, Validation Protocols (IQ/OQ/PQ), Traceability Matrices, and Validation Summary Reports.
• Coordinate and participate in system verification and testing activities, including user acceptance testing and regression tests.
• Collaborate with cross-functional teams (IT, Quality, Operations, Engineering, Laboratory, Vendors) to define validation scope, protocols, and acceptance criteria.
• Manage deviations, incidents, and change controls related to validated computerized systems.
• Ensure proper documentation and evidence is maintained to support audit readiness and regulatory inspections.
• Support periodic review and re-validation of existing systems as required by internal or regulatory changes.
• Provide training and guidance to system owners and end users on CSV and data integrity best practices.
• Maintain up-to-date knowledge of relevant regulations, industry guidelines, and new technologies impacting CSV.

EDUCATION/QUALIFICATIONS

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field.
• 4+ years' experience in Computer System Validation within the pharmaceutical, biotechnology, or other GxP-regulated industry.
• Strong knowledge of GxP principles, 21 CFR Part 11, EU Annex 11, and other relevant global CSV regulations and guidance.
• Familiarity with a range of computerized systems (e.g., LIMS, MES, ERP, SCADA, PLC, laboratory instruments).
• Experience with writing and executing validation plans and protocols.
• Excellent documentation, organizational, and communication skills.
• Analytical problem-solving with attention to detail.
• Ability to work independently and in cross-functional teams.
• Experience with risk-based approaches to validation (e.g., ISPE GAMP 5) preferred.