Process Engineer 3

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.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: You’ll DoServes as point of contact to the Engineering, Procurement, Construction Management (EPC) providerSecures on time delivery and ensures quality from Fujifilm and EPCM provider for moderate complexity equipment packagesDevelops and aligns moderate complexity plans and provides mitigations, as neededReviews piping and instrumentation diagram (P&IDs) and other process design documentsProvides direction to detailed design activities in partnership with the EPCM providerWrites User Requirement Specifications (URSs)Supports Factory Acceptance Testing (FAT), Commissioning Qualification and Validation (CQV), and start-up activitiesServes as on-call support for process equipmentReviews, redlines, and approves P&IDs and other technical documents as the technical authorityLeads system impact assessments and quality risk assessments for process equipmentPerforms technology transfer (TT) activities related to process equipmentSupports execution of Good Manufacturing Practices (GMP) runsProvides technical support for root cause analysis (RCA) and process deviation investigationsLeads or assists with deviations, change controls, and corrective and preventive action (CAPA) closuresMakes decisions regarding technical risk assessments for new manufacturing equipmentProvides on-floor manufacturing support for equipment issuesProvides 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 costSupports supplier technical evaluations, risk assessments, and equipment evaluation and qualificationConducts training and presents information to team or other stakeholdersCross-trains on unit operations to assist team with achieving deliverablesCollaborates with other departments, such as Quality, Manufacturing, Process Science, Maintenance, and AutomationOther duties, as assignedBasic RequirementsBachelor’s degree in Chemical or Biotechnology Engineering, or another related field with 5 years of Engineering or other relevant technical experience; orMaster’s in Chemical or Biotechnology Engineering with 3 years of Engineering or other relevant technical experienceExperience in Life Science or other regulated industryExperience with Engineering drawings and Quality Systems (e.g., deviation management, change control, CAPA, document management system)Preferred Requirements• 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 processesWORKING CONDITIONS & PHYSICAL REQUIREMENTSAbility to ascend or descend ladders, scaffolding, ramps, etc.Ability to stand for prolonged periods of timeAbility to sit for prolonged periods of timeAbility to conduct activities using repetitive motions that include writs, hands and/or fingers'Ability to operate machinery and/or power toolsAbility to conduct work that includes moving objects up to 33 lbs.Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motionsFujifilm is committedto providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ().

Created: 2026-01-15