Computerized System Validation (CSV) Site Lead
Core
Own and govern Computerized System Validation (CSV) strategy and delivery for Operational Technology (OT) platforms supporting Manufacturing and QC Laboratories.
Role type
Senior individual contributor CSV Site Lead
Builds
Validated OT systems (PCS, MES, SCADA, Historians, lab systems) for biotherapeutics manufacturing and quality control
Domain
Pharmaceutical manufacturing / Regulatory compliance / Operational Technology
Required skills
GAMP5, 21 CFR Part 11, Annex 11, SDLC, data integrity, OT system validation, vendor QMS governance, regulatory inspection readiness, change control, CAPA management
Preferred skills
Strategic direction, cross-functional partnership, coaching and training, continuous improvement
Technologies
PCS, MES, SCADA, Historians, laboratory systems
Responsibilities
Govern CSV strategy and risk-based approach; Lead CSV delivery through external partners; Maintain validated state of OT systems throughout lifecycle; Support regulatory inspections and audit readiness; Partner cross-functionally with Automation, Manufacturing, QC, Quality, IT, and Global CSV teams; Provide coaching and drive continuous improvement
Seniority
Senior, hands-on IC