CSV Engineer

Designation : CSV Engineer

Location: Gajraula, UP

Qualification: BE/B-Tech in Relevant Department.

Experience: Min. 03 Years

Salary: As per market standard

Required Criteria for CSV Engineer.

• Develop and execute validation protocols (IQ, OQ, PQ and Other documents required as per GAMP categorization) for computer systems.
• Ensure compliance with regulatory requirements (e.g., FDA 21 CFR Part 11, GAMP 5).
• Perform risk assessments and develop mitigation strategies.
• Handling and mitigation action for discrepancies during CSV activity.
• Collaborate with cross-functional teams to ensure validation activities are completed on time.
• Maintain validation documentation and ensure it is up-to-date.
• Conduct training sessions for staff on validation procedures and regulatory requirements.
• Participate in audits and inspections as required.
• Strong knowledge of regulatory requirements and industry standards
• Excellent problem-solving and analytical skills
• Strong communication and interpersonal skills