Computer System Validation (CSV) Senior Engineer

Summary: BioPharma Consulting JAD Group is seeking a talented and experienced Computer System Validation (CSV) Senior Engineer to join our team. As a CSV Senior Engineer, you will play a critical role in ensuring compliance with regulatory requirements and industry standards for computerized systems used in pharmaceutical manufacturing processes. You will lead and execute computer system validation activities and provide expertise in CSV best practices.

Functions: 

• Generate, obtain approvals, and execute validation deliverables for computerized systems and relevant infrastructure, including Validation Plans, Requirements Specification, Risk Assessments, Installation/Operational Qualifications, Traceability Matrices, and Validation Final Reports, ensuring documents meet regulatory and procedural requirements of 21 CFR Part-11, Annex-11 Data Integrity and GAMP5 among others. 

• Plan and organize validation...