Bausch Advanced Technologies manufactures customized pharmaceutical packaging machinery. The Validation Technician 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 Technician begins documentation of each machine using basic templates written to GAMP 5 standards and must customize each documentation package to customer specifications. The Validation Technician works daily with the mechanical, electrical, and controls engineers who designed the machine. Required deliverable documentation includes, but is not limited to:
Functional specification
Design specification
Parts catalog
Spare and wear parts list
Operating manual
The Validation Technician also works with the project manager and customer to create validation and test documents. At the end of each project, the Validation Technician is expected to participate with the customer during the Factory Acceptance Test. Testing includes machine inspection, electrical schematic check, alarm verification, functional tests, etc.
Authority:
Reports to Validation Manager
Education and Qualifications:
Minimum 2 years’ experience
Bachelor’s Degree
ASME or ASEE
BAUSCH Advanced Technology Group designs, manufactures, and services custom aseptic fill-finish packaging equipment for the pharmaceutical and related industries.
