Validation Supervisor
Core
Lead and transform the validation organization to ensure operational excellence, compliance readiness, and strategic growth in a biopharmaceutical/manufacturing setting.
Role type
Senior Validation Engineering Supervisor
Builds
Risk-based, scalable validation function supporting process, equipment, utility, and system validation activities
Domain
Life Sciences / Biopharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP regulations, Process Validation, Equipment Qualification (IQ/OQ/PQ), Risk-based validation principles, Change control, deviations, and CAPA systems, Metrology and calibration practices
Preferred skills
Prior leadership or supervisory experience, Biopharmaceutical/medical device/life sciences manufacturing experience, Lean Six Sigma, Regulatory inspection support
Technologies
None explicitly stated
Responsibilities
Supervise and develop a team of validation engineers, metrology personnel, and validation technicians; Set priorities, allocate resources, and manage execution of validation projects; Establish and maintain risk-based validation strategies aligned with regulatory standards; Govern site-wide validation programs including process, equipment, utility, and system validation; Review and approve validation protocols, reports, deviations, risk assessments, and change controls; Oversee Process Validation activities to ensure manufacturing processes consistently meet defined requirements; Direct Equipment/System Validation efforts including IQ/OQ/PQ execution; Ensure metrology and calibration systems maintain reliable and compliant measurements; Participate in audits, inspections, investigations, and continuous improvement programs
Seniority
Senior, hands-on IC with leadership responsibilities
