Computerized Systems Validation (CSV) & Data Integrity Lead
Core
Lead Computerized Systems Validation (CSV) and Data Integrity programs to ensure GxP system compliance, inspection readiness, and alignment with regulatory requirements.
Role type
Senior IC Quality/Compliance Lead (CSV & Data Integrity)
Builds
Validated GxP computerized systems and robust data integrity frameworks for regulated manufacturing environments.
Domain
Pharmaceutical/Biotechnology/Medical Device Manufacturing (Regulatory Compliance)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computerized Systems Validation (CSV), Data Integrity (ALCOA+), GxP compliance, Risk-based validation (CSA), Regulatory knowledge (Annex 11, 21 CFR Part 11, GAMP 5), Change control management, Vendor validation oversight, Technical leadership, Cross-functional collaboration
Preferred skills
Validation of automation/manufacturing systems (DCS, PLC, SCADA, BMS, Historian), Experience with TrackWise
Technologies
TrackWise, DCS, PLC, SCADA, BMS, Historian
Responsibilities
Own and improve CSV and Data Integrity procedures and governance; Maintain site inventory of GxP systems; Develop validation strategies, plans, risk assessments, and reports; Lead Data Integrity assessments and gap analyses; Serve as SME during regulatory inspections and audits; Provide technical leadership and mentoring to cross-functional teams; Monitor regulatory developments and implement updates.
Seniority
Senior, hands-on IC with technical leadership