Process Engineer 1

Fujifilm•Holly Springs, NC

1d•Onsite

About The Position

The Process Engineer 1 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.

Requirements

Bachelor’s degree in Chemical Engineering, Biotechnology Engineering, or another related fielc
0-1 years of engineering or other relevant technical work experience

Nice To Haves

Experience working in a cGMP environment or other highly regulated industry
Prior experience with mammalian cell culture processes

Responsibilities

Supports on time delivery and ensures quality from Fujifilm and Engineering, Procurement, Construction Management (EPCM) provider
Supports piping and instrumentation diagram (P&IDs) and other process design document review
Provides input to detailed design activities in partnership with EPCM provider
Writes User Requirement Specifications (URSs)
Supports Factory Acceptance Testing (FAT), Commissioning Qualification, and Validation (CQV), and start-up activities with supervision
Serves as on-call support for process equipment
Reviews, redlines, and approves P&IDs and other technical documents with supervision
Contributes to system impact assessments and quality risk assessments for process equipment
Supports 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
Assists with deviations, change controls, corrective and preventive action (CAPA) closures
Supports technical risk assessments for new manufacturing equipment
Provides on-floor manufacturing support for equipment issues
Cross-trains on unit operations to assist team with meeting deliverables
Collaborates with other departments, such as Quality, Manufacturing, Maintenance, Validation, and Safety.
Other duties, as assigned