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 facilities.
Domain
Biopharmaceuticals / GxP Compliance / Computer Systems Validation
Required skills
CSV strategy development, GAMP 5, 21 CFR Part 11, EU Annex 11, data integrity (ALCOA+), risk-based validation, team leadership, regulatory inspection readiness, change control management, vendor assessment, technical writing.
Preferred skills
Equipment commissioning and qualification (IQ/OQ/PQ), biologics manufacturing experience, aseptic processing knowledge, familiarity with DeltaV, MES, SAP.
Technologies
DeltaV, MES, SAP, Laboratory Information Management Systems (LIMS), Building Management Systems (BMS)
Responsibilities
Lead CSV programme across MPCC and SDPF facilities; develop and maintain CSV strategy and validation master plan; oversee authoring and review of validation deliverables; ensure data integrity compliance; manage CSV team and performance; coordinate with equipment qualification team; act as primary CSV representative during regulatory inspections.
Seniority
Manager, hands-on IC with team leadership