Senior CSV Analyst

The candidate will lead computer system validation (CSV) compliance activities for capital and strategic projects. Experience working with CSV in manufacturing automation systems such as DeltaV, PI Historian, PLC, or Lab Automation Systems is required. Responsibilities:

• Lead computer system validation (CSV) compliance activities for capital and strategic projects.
• Develop, review, and approve validation lifecycle deliverables in accordance with applicable standard operating procedures (SOPs) and regulatory requirements, such as 21 CFR Part 11.
• Provide compliance guidance to project teams on the Software Development Life Cycle (SDLC), Computer Software Assurance (CSA), qualification, and validation approaches.
• Participate in project meetings and CSV compliance reviews.
• Assist with project change controls and CSV compliance-related risk assessments.
• Maintain project CSV compliance trackers, metrics, and reporting.
• Approve SDLC documents as part of the technical unit.

• Minimum 5 years of experience in Computer System Validation (CSV), CSA, Automation Compliance, Shopfloor, Enterprise, Lab, and Quality Systems within a regulated pharmaceutical or biotechnology environment.
• Experience working in CSV for manufacturing automation systems such as DeltaV, PI Historian, PLC, or Lab Automation Systems.
• Strong knowledge of GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, risk-based validation, and CSA principles.
• Solid understanding of the Software Development Life Cycle (SDLC), Change Management, and Deviation processes.
• Proven experience supporting capital projects and Good Manufacturing Practice (GMP) computerized systems.
• Strong stakeholder management and communication skills.
• Ability to work independently across multiple projects and sites.