CSV Engineer

Computer System Validation specialist supporting a major capital project at a pharmaceutical manufacturing site. Responsible for ensuring all GxP IT/OT and manufacturing control systems are delivered in compliance with regulatory and quality standards. Works with engineering, automation, IT, quality, and external vendors to deliver commissioning, qualification, and validation activities.

CSV Leadership & Governance

• Act as CSV subject matter expert for capital project systems.
• Support development of Validation Master Plans and CSV strategies.
• Ensure risk-based lifecycle validation aligned with regulatory expectations.

Project Validation Delivery

• Support validation of manufacturing control systems (e.g. PLC, SCADA, DCS).
• Ensure readiness for FAT, SAT, IQ, OQ, PQ, system release, and operational handover.
• Coordinate validation activities across engineering, IT/OT, automation, and quality teams.

Validation Documentation

• Author/review validation documentation including:
• User Requirements (URS)
• Functional/Design Specifications
• Risk Assessments
• Traceability Matrices
• Test protocols and reports
• Validation summary and release documentation
• Ensure documentation is audit-ready and compliant.

Testing & Defect Management

• Oversee validation test execution.
• Manage deviations, defects, and CAPA actions.
• Ensure appropriate access control, data integrity, and approval workflows.

Data Integrity & Compliance

• Ensure ALCOA+ data integrity principles are embedded in systems and validation activities.
• Support regulatory compliance (e.g. electronic records/signatures requirements).
• Contribute to audit and inspection readiness.

Change Control & Lifecycle Management

• Support change control processes for validated systems.
• Conduct impact assessments and define revalidation requirements.
• Maintain system lifecycle documentation and periodic reviews.

Vendor & System Oversight

• Review vendor validation documentation and leverage supplier testing where appropriate.
• Support vendor qualification and validation responsibility agreements.

Project Reporting & Stakeholder Engagement

• Track validation deliverables and milestones.
• Provide updates to project leadership and escalate risks when needed.
• Collaborate with engineering, operations, IT, quality, and external partners.

• Degree in engineering, life sciences, or related discipline (or equivalent experience).
• Experience in Computer System Validation within regulated environments.
• Knowledge of GxP, data integrity, and computerized system regulations.
• Experience validating manufacturing automation systems and integrated IT/OT environments. xcfaprz
• Strong documentation, stakeholder communication, and project coordination skills.