Sr Manager, Validation
Core
Managing process validation for manufacturing equipment, utility systems, facilities, and processes to ensure regulatory compliance and product safety.
Role type
Senior Manager, Validation
Builds
Validated manufacturing systems and processes for drug products
Domain
Pharmaceutical manufacturing / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process validation management, FDA audit representation, vendor/contractor management, budget planning, change control system management, multi-disciplinary team leadership, sterilization validation expertise
Preferred skills
Progressive leadership experience, project management, pharmaceutical/biotech industry background
Technologies
None explicitly stated
Responsibilities
Manage validation activities for manufacturing equipment and processes; Represent the department during FDA audits and meetings; Approve testing protocols and acceptance criteria; Audit and qualify vendors and contractors; Prepare and defend departmental budgets; Participate in engineering project teams for cGMP compliance
Seniority
Senior, hands-on IC with management duties
