Position OverviewThe Senior Process Engineer 1 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.
Company OverviewFUJIFILM 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: ;br>
Job DescriptionWhat You'll Do- Serves as point of contact to the Engineering, Procurement, Construction Management (EPCM) provider for high complexity equipment packages.
- Ensures on time delivery and quality from Fujifilm and EPC provider for high complexity equipment packages.
- Develops and aligns high complexity plans and provides mitigations, as needed.
- Reviews piping and instrumentation diagrams (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 Assessment Tests (FATs), 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 deviation 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.
- Identifies 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.
Knowledge, Skills, and Abilities - Ability to develop effective working relationships internally and externally.
- Effective communication, both written and oral.
- Advanced problem-solving skills.
- Advanced project management skills.
- Ability to effectively present complex information to others.
- Ability to provide feedback to others, including leaders.
- Ability to adapt communication style to differing audiences and advise on difficult matters.
- Ability to remain up to date on regulatory and quality requirements for manufacturing.
Minimum Qualifications- Bachelor's degree in Chemical or Biotechnology Engineering, or another 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.
Preferred Qualifications- Prior experience working in a cGMP environment or other highly regulated industry.
- Experience with large scale mammalian cell culture processes, 2000 I.
- Large scale capital project experience, > $500M USD.
Physical Requirements:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to:
- May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.
- Ability to discern audible cues.
- Ability to ascend or descend ladders, scaffolding, ramps, etc..
- Ability to stand for prolonged periods of time for up to 120 minutes.
- Ability to sit for prolonged periods of time for up to 240 minutes.
- Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers.
- Ability to operate machinery and/or power tools.
- Ability to conduct work that includes moving objects up to 33 pounds.
- Ability to bend, push or pull, reach to retrieve materials from 18'' to 60'' in height, and use twisting motions.
- Will work in warm/cold environments, 60-90 range.
- Will work in small and/or enclosed spaces.
- Will work in heights greater than 4 feet.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
*LI-Onsite
EEO InformationFujifilm is committed to 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.
ADA InformationIf 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 ().
