Associate Manager, Engineering - Validation
Core
Manage the validation lifecycle program for facility and equipment utilities to ensure compliance with regulatory requirements in pharmaceutical manufacturing.
Role type
Associate Manager, Engineering Validation
Builds
Validated pharmaceutical manufacturing facilities and equipment
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
People management, cGMP knowledge, regulatory compliance, project management, cross-functional collaboration, training program management, deviation investigation, problem-solving
Preferred skills
Engineering or Life Science degree, experience in pharmaceutical validation role
Technologies
Validation SOPs, Validation Master Plan, cGMPs
Responsibilities
Supervise day-to-day Validation activities, review and approve Validation SOPs/Plans, manage internal and external validation resources, liaise with system owners and quality units, plan and manage on-job training programs, participate in regulatory inspections and client audits, plan and manage validation efforts for large-scale change projects, provide oversight for validation deviation investigations.
Seniority
Manager, hands-on leadership