Senior Validation Engineer
Core
Execute and support validation/qualification activities for processes, equipment, computerized systems, utilities, facilities, and cleaning procedures at the Batam Plant.
Role type
Senior Validation Engineer (Manufacturing)
Builds
Validated manufacturing processes and equipment for medical devices
Domain
Medical device manufacturing
Required skills
validation lifecycle management, technical report writing, protocol preparation and review, SOP training, capital project validation support, compliance assurance
Preferred skills
tech transfer project support, complex project execution
Technologies
GMP, 21 CFR Part 11, IQ/OQ/PQ
Responsibilities
Execute site validation/qualification activities, support validation efforts for tech transfer projects, prepare and review validation protocols, train on validation protocols and site SOPs, support validation for large capital procurement projects, ensure compliance and provide technical support to the validation team
Seniority
Senior, hands-on IC
