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 and check documentation for GMP compliance
• Collaboration and or Creation of Validation summaries

Requirements

• Degree in Engineering/Pharmaceutical/Computer Science or related studies
• At least 4 years of experience in a CSV role within the pharmaceutical industry is a must.
• Good fundamental technical knowledge of automation system such as Siemens PCS7, DeltaV or IT system to assist automation engineers in developing life cycle documentation.
• Knowledgeable in GAMP5, ANSI/ISA-88 and 21 CFR PART 11 requirements