The Process Engineer 2 will provide engineering guidance to support capital projects, technology transfer, and manufacturing operations. This will ensure compliance with all safety, regulatory, and engineering requirements. This role will adhere to product and customer requirements, and work towards optimizing plant efficiency and profitability.

This position reports to the Director, Process Engineering supporting the Process Equipment team for the Galaxy project, a greenfield construction project. The initial assignment is to assume the Responsible Engineer role for owner furnished small equipment for the capital project. Additionally, this role will support the Responsible Engineer responsible for washers, autoclaves, and CIP unit operations. As the site moves into commercial operations circa 2025, this position is planned to continue as a Process Engineering role supporting washers, autoclaves, and CIP.

* Serves as point of contact to the Engineering, Procurement, Construction Management (EPCM) provider
* Secures on time delivery and ensures quality from Fujifilm EPCM provider for equipment packages with limited complexity
* Develops and aligns basic plans and provides mitigations, as needed
* Reviews piping and instrumentation diagrams (P&IDs) and other process design documents
* Provides direction to detailed design activities in partnership with the EPCM provider
* Writes User Requirements Specifications (URSs)
* Supports Factory Acceptance Testing (FAT), Commissioning Qualification and Validation (CQV), and start-up activities
* Serves as on-call support for process equipment
* Reviews, redlines, and approves P&IDs and other technical documents with limited supervision
* Performs system impact assessments and quality risk assessments for process equipment
* Performs technology transfer (TT) activities related to process equipment
* Supports execution of Good Manufacturing Practices (GMP) runs
* Provides technical support for root cause analysis (RCA) and process deviation investigations
* Leads or assists with deviations, change controls, and corrective and preventive action (CAPA) closures
* Makes decisions regarding technical risk assessments for new manufacturing equipment
* Provides on-floor manufacturing support for equipment issues
* Provides process equipment training and consultation on topics within assigned area
* Supports continuous improvement projects in partnership with Maintenance and Manufacturing
* Cross-trains on multiple unit operations to assist team with achieving deliverables
* Collaborates with other departments, such as Quality, Manufacturing, Process Science, Maintenance, and Automation
* Other duties, as assigned

Requires a Bachelor's degree in Chemical or Biological Engineering, or related field. Requires 2 yrs of Engineering experience, including experience in a Life Sciences or other regulated industry. Requires Experience with Engineering drawings and using Quality Systems (e.g., deviation management, change control, CAPA, document management system). Prior experience working in at least one unit operation in a pharmaceutical or Life Sciences environment is preferred. Experience with mammalian cell culture is also preferred.