Senior CSV Engineer

Job Summary

To support a strategic software integration program, the full-time Senior CSV Engineer will provide quality and validation expertise throughout the lifecycle of computerized systems in a remote role, ensuring compliance with GxP requirements and data integrity principles.

Key responsibilities

• Support the validation lifecycle of computerized systems in accordance with GAMP 5 and internal quality procedures
• Provide quality oversight for software implementation, integration, and data migration activities
• Develop and review validation deliverables, including validation plans, risk assessments, and change controls

Required qualifications

• Bachelor's degree in Life Sciences, Computer Science, Engineering, Information Technology, or a related discipline
• Minimum 10 years of experience in Computerized System Validation (CSV) within the pharmaceutical, biotechnology, or medical device industry
• Strong knowledge of GxP, GAMP 5, CSA, and data integrity principles (ALCOA+)
• Proven experience supporting system implementations, integrations, and data migration projects
• Experience with system decommissioning, archival, and record retention requirements