Manager, Engineering Computer Systems Validation (CSV)
Core
Lead the Computer Systems Validation (CSV) programme for biologics and sterile drug product facilities, ensuring compliance with GxP regulations and data integrity standards.
Role type
Manager, Engineering Computer Systems Validation (CSV)
Builds
Validated computerised systems for process control, manufacturing execution, and enterprise operations in biologics/sterile drug manufacturing
Domain
Biopharmaceuticals / GxP-regulated manufacturing
Required skills
CSV strategy development, GAMP 5 compliance, 21 CFR Part 11, EU Annex 11, data integrity (ALCOA+), risk-based validation, team leadership, regulatory inspection support, change control management, vendor assessment
Preferred skills
Equipment commissioning and qualification (IQ/OQ/PQ), biologics manufacturing experience, aseptic processing knowledge, familiarity with DeltaV, MES, SAP
Technologies
GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+, DeltaV, MES, SAP
Responsibilities
Lead CSV programme across multiple facilities, develop and maintain CSV strategy and validation master plan, oversee authoring and review of validation deliverables, ensure data integrity compliance, manage CSV team, coordinate with equipment qualification, act as primary CSV representative during regulatory inspections, provide training and mentorship
Seniority
Manager, hands-on leadership