Process Engineer 1

About the role

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.

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

Minimum requirements

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

Preferred qualifications

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