Sr Process Engineer 1/Process Engineer 3

FUJIFILM Diosynth Biotechnologies•Holly Springs, NC

32d

About The Position

The Process Engineer 3 provides 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 or Biotechnology Engineering, or another related field with 5 years of Engineering or other relevant technical experience; or
Master's in Chemical or Biotechnology Engineering with 3 years of Engineering or other relevant technical experience
Experience in Life Science or other regulated industry
Experience with Engineering drawings and Quality Systems (e.g., deviation management, change control, CAPA, document management system)

Nice To Haves

Bachelor's degree in Chemical or Biotechnology Engineering, oranother related field with 8 years of Engineering or other relevant technical experience; or
Master's degree in Chemical or Biotechnology Engineering with 6 years of Engineering or other relevant technical experience
Experience in Life Science or other regulated industry
Experience with Engineering drawings and Quality Systems (e.g., deviation management, change control, CAPA, document management system)
Proficient experience in multiple unit operations within the assigned plant section

Responsibilities

Serves as point of contact to the Engineering, Procurement, Construction Management (EPC) provider
Secures on time delivery and ensures quality from Fujifilm and EPCM provider for moderate complexity equipment packages
Develops and aligns moderate complexity plans and provides mitigations, as needed
Reviews piping and instrumentation diagram (P&IDs) and other process design documents
Provides direction to detailed design activities in partnership with the EPCM provider
Writes User Requirement 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 as the technical authority
Leads 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(s)
Participates in identifying continuous improvement projects within unit operations, in partnership with Manufacturing when applicable, to improve manufacturability, reliability, yield and cost
Supports supplier technical evaluations, risk assessments, and equipment evaluation and qualification
Conducts training and presents information to team or other stakeholders
Cross-trains on 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