Manager, Facilities & Software Validations
Core
Managing and coordinating validation efforts for facilities, utilities, and computer equipment across multiple sites to ensure compliance with regulatory and customer requirements.
Role type
Manager, Facilities & Software Validations
Builds
Validated facility systems, utilities, and computerized systems for biopharma clients
Domain
Biopharmaceutical manufacturing and regulated industries
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation lifecycle management, Computer System Validation (CSV), GAMP 5 methodology, risk assessment, change control, regulatory compliance (FDA 21 CFR), budget management, team leadership, data integrity (ALCOA+)
Preferred skills
Supervising validation personnel, presenting to stakeholders, problem resolution, strategic planning
Technologies
HVAC systems, water systems, compressed air, gases, computerized systems, validation software
Responsibilities
Oversee and manage validation supervisors and engineers; Develop and maintain Validation Master Plan and policies; Plan and execute validation of facilities, cleanrooms, and utilities; Lead CSV activities in accordance with GAMP 5, FDA, and ISO requirements; Review and approve validation documentation including URS, risk assessments, IQ, OQ, PQ, and summary reports; Serve as risk management representative on cross-functional teams; Participate in audits and regulatory inspections.
Seniority
Manager, hands-on leadership
