IT Validation Contractor

Job Summary

Providing quality oversight of computerized system validation activities, the part-time IT Validation Contractor will manage vendor oversight, review validation deliverables, and ensure compliance with regulatory requirements while working remotely for approximately 10-20 hours per week.

Key responsibilities

• Provide Quality oversight of vendors and contractors performing validation activities and monitor their progress against timelines
• Review and approve key validation deliverables, ensuring a risk-based validation approach consistent with regulatory standards
• Act as the Quality point of contact for validation of GCP, PV, and GLP-related systems, supporting audits and regulatory inspections

Required qualifications

• Bachelor's degree in a scientific, technical, or IT-related field, or equivalent experience
• 7+ years of experience in computerized system validation in a regulated pharmaceutical, biotech, or CRO environment
• Working knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, and ICH E6(R3)
• Experience overseeing third-party vendors or contractors performing validation work
• Experience with GCP, PV, and/or GLP systems, such as safety databases, eTMF, EDC, or LIMS