CSV Specialist

The CSV Engineer is responsible for validating GxP computer systems and ensuring compliance with global procedures, data integrity standards, and applicable regulations. The role partners closely with Quality Systems, QC, Project Management, and technical SMEs to deliver high-quality validation documentation and execution.

Responsibilities

• Lead full validation lifecycle per GAMP 5 and cGxP requirements.
• Develop and maintain Validation Plans, URS, OQ/PQ protocols, traceability matrices, and summary reports.
• Author and execute test scripts in HP ALM with complete requirement linkage.
• Validate system configurations, data flows, and electronic records for compliance with 21 CFR Part 11.
• Perform regression testing to ensure changes do not impact existing functionality or data integrity.
• Manage defects, deviations, and root cause documentation within electronic systems.
• Collaborate with business and system SMEs to translate requirements into validated system states.
• Maintain strong communication and cross-functional coordination.

• Bachelor’s degree in engineering or life sciences; equivalent experience considered.
• Minimum 5 years in pharmaceutical or biopharmaceutical CSV.
• Strong understanding of cGxP, GAMP5, S88, 21 CFR Part 11.
• Experience with TrackWise, Veeva, Kneat, ALM, or similar documentation systems.
• Familiarity with MODA, LabWare, or other QC/LIMS platforms preferred.
• Proficient in Microsoft Teams and electronic collaboration tools.