Process Validation Manager
Core
Lead Process Validation, Cleaning Validation, and Continued Process Verification (CPV) for a biopharmaceutical manufacturing site, ensuring regulatory compliance and product quality.
Role type
Manager, Process Validation
Builds
Validated commercial processes and cleaning protocols for biologics
Domain
Biopharmaceuticals / cGMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process Validation lifecycle management, Cleaning Validation, Continued Process Verification (CPV), Regulatory compliance (FDA/TGA/EMA), Team leadership and mentorship, Validation planning and resource modeling, Risk assessment methodologies, Technical documentation and regulatory submission authoring, Root cause analysis and CAPA management, Change control management, Statistical analysis
Preferred skills
PPQ experience, Tech transfer initiatives, Strategic vision for site validation, Matrix management influence
Technologies
Trackwise, Discoverant, MS Office, Project
Responsibilities
Lead Process Validation team to uphold Customer Allegiance, Right-First-Time, and On-Time Delivery; Manage and mentor customer-facing engineers; Coordinate validation execution including training and protocol tracking; Develop workload/resource plans for PPQ and commercial stages; Support regulatory filing strategies and defend validation approaches to agencies; Align site practices with global guidance and procedures; Coordinate participation in Tech Transfer and capital projects.
Seniority
Manager, hands-on IC with team leadership
