Bausch Advanced Technologies manufactures customized pharmaceutical packaging machinery. The Validation Engineer works in the Documentation Department to prepare machine validation documents and other deliverable documents. They are also responsible for equipment validation and verification.
The Validation Engineer begins documentation of each machine using basic templates written to GAMP 5 standards and must customize each documentation package to customer specifications. The Validation Engineer works daily with the mechanical and electrical engineers who designed the machine. Required deliverable documentation includes, but is not limited to:
Spare and wear parts list
The Validation Engineer also works with the project manager and customer to create validation and test documents. At the end of each project, the Validation Engineer is expected to participate with the customer during the Factory Acceptance Test. Testing includes machine inspection, electrical schematic check, alarm verification, functional tests, etc.
Reports to documentation manager.
Education and Qualifications:
Minimum 2 years’ experience
ASME or ASEE