FUJIFILM Biotechnologies · 10 hours ago
Process Engineer 3
Holly Springs, NC
Full-time
Onsite
Senior Level
5+ years expFUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. The Process Engineer 3 provides engineering guidance to support capital projects, technology transfer, and manufacturing operations while ensuring compliance with safety, regulatory, and engineering requirements.
BiotechnologyHealth CareManufacturing
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
Qualification
Required
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)
Preferred
Prior experience working in a cGMP environment or other highly regulated industry
Experience working in at least one unit operation in a pharmaceutical or Life Science environment
Experience with mammalian cell culture processes
Company
FUJIFILM Biotechnologies
For over 30 years, FUJIFILM Biotechnologies' mission has been advancing tomorrow’s medicine.
Founded in 2011Morrisville, North Carolina, USA
1001-5000 employees
H1B Sponsorship
FUJIFILM Biotechnologies has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Late StageLeadership Team
Lars Petersen
President & Chief Executive Officer
Morten Munk
Director - Global Alliance Management
Recent News
Morningstar.com
2025-10-30
Company data provided by crunchbase