We are looking for a

Validation Engineer 1

Clinton, CT, USA

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, 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 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.
  • Prepare validation documents, operating manuals, and additional documents for customer projects.
  • Prepare internal documents and specifications.
  • Perform FAT and SAT testing.
  • Participate in SAT and IQ/OQ testing at customer site.
  • Work with engineers and assembly to complete tasks.

Authority:

Reports to Validation Manager

Education and Qualifications:

Minimum 2 years’ experience
Bachelor’s Degree
ASME or ASEE

Job typeFull-time

Pay$60,000 – $65,000 per year

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