Process Engineer 1
Full-time
FUJIFILM Biotechnologies
Position Overview 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. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: Job Description What You'll Do:
- 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
- Bachelor's degree in Chemical Engineering, Biotechnology Engineering, or another related fielc
- 0-1 years of engineering or other relevant technical work experience
- Experience working in a cGMP environment or other highly regulated
industry - Prior experience with mammalian cell culture processes
Vacancy posted 4 days ago
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