Computer Systems Validation (CSV) Engineer

Key Responsibilities Work with Engineers to develop Computer Validation Strategy, plans, protocols, reports, risk assessment, requirement traceability matrix etc for any new or change induced validation system / activities. Schedule, organize and coordinate at detailed site level, validation activities with cross functional groups Assist in raising Change Control to update Automation System Life cycle documentation, SOPs, Risk Assessment, Requirement Traceability Matrix etc. Review and approve of validation protocols, reports and deliverables for the specialized validation area Define requirements for validation activities and ensure regulatory compliance based on Risk Assessment Creation and/or review of validation lifecycle documents: User Requirement Specification, Functional Specification, Risk Assessments, Validation Protocols (IQ/OQ/PQ/CPV) and Reports, Study Protocols and Reports, Requirement Traceability Matrix, CFR Part 11 assessment and validation submission dossier Review an...