Test Equipment and Method Validation Engineer
Core
Validation and qualification of processes and equipment, including establishing and maintaining Validation Master Plans (VMP) and local procedures in compliance with GHTF guidelines.
Role type
Validation Engineer
Builds
Validated test equipment and methods for medical product manufacturing
Domain
Medical devices / Process Engineering
Required skills
Process validation, equipment qualification, risk assessment, statistical techniques, procedure development, resource planning, training delivery
Preferred skills
Cleanroom experience
Technologies
Microsoft Office Suite
Responsibilities
Validate and qualify processes and equipment; Contribute to requirement specification and equipment implementation; Establish and maintain validation procedures and forms; Develop and maintain Validation Master Plans; Coordinate revalidation resource planning with maintenance and production; Train employees on validation methods.
