Validation Engineer

The Operations Validation Group at the Allston Landing manufacturing site is responsible for validating the manufacturing equipment/systems used to manufacture, store, and test, products. This may include capital and non-capital projects. All activities are done in accordance with standards and industry regulatory requirements. This encompasses work processes that originate with the identification of new or revised assets and the design, installation, verification, validation, and requalification of assets.

Responsibilities include:

• Commissioning, qualification and validation of facilities, equipment and utilities. This also includes cleaning, sterilization, and manufacturing processes, as well as, presenting validation documents to regulatory agencies
• Computer systems validation
• Writing, reviewing, and approving various validation related documents (protocols, final reports, SOPs, etc.) for continuous quality system improvements
• Developing Validation Plans for medium to large size validation projects, maintaining Validation Master Plans and periodic reporting, as well as reviewing and approving peer CQV protocols and reports
• Generating complex protocols using a risk based approach that meets current regulatory requirements and industry standards, as well as performing Design Qualification

​The Validation Engineer I serves as a validation subject matter expert and must be able to apply current industry standards to validation documents and strategies at the site. The successful candidates has working knowledge of regulatory requirements and industry practices and is able to apply this knowledge in the development of site validation procedures and policies.