CSV & Equipment Compliance Manager
Core
Ensure regulatory compliance for Computer System Validation (CSV) activities and deliver IT support for desktops and instrument workstations in GMP-regulated manufacturing environments.
Role type
CSV & Equipment Compliance Manager (GMP/IT hybrid)
Builds
Validated computerized systems and qualified equipment for production processes
Domain
Life Sciences / GMP Manufacturing / IT Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CSV task planning, risk-based validation, GAMP 5, EU GMP Annex 11, FDA 21 CFR Part 11, documentation preparation and review, system selection, implementation qualification, change control, data integrity, supplier qualification, staff training, IT support for GMP environments, vendor liaison
Preferred skills
Unicorn, Factory Talk, Rockwell Systems, Empower, Chromeleon, TIL Foundation, GxP compliance, Windows Server, networking, laboratory informatics systems
Responsibilities
Identify and plan CSV tasks, prepare and approve CSV documentation, coordinate software validations and equipment qualifications, act as Deputy System Administrator, provide expert support during audits, contribute to QMS improvement, support supplier qualification, deliver staff training, provide IT support for instrument workstations, serve as interface between business teams and Corporate IT
Seniority
Mid-Senior, hands-on IC