Process Engineer I, Drug Product

FUJIFILM; Holly Springs (NC); Sur place; USD 65 000 - 90 000; Plein temps

Résumé du poste

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. The Process Engineer 1 will provide engineering guidance for capital projects, technology transfer, and manufacturing operations, ensuring safety, regulatory compliance, and alignment with product and customer requirements.

In this role you will review P&IDs, assist with detailed design activities with the EPCM provider, write URSs, and support FAT, CQV, and start-up activities.

Qualifications

• Bachelor’s degree in Chemical Engineering, Biotechnology Engineering, or another related field.
• 0-1 years of engineering or other relevant technical work experience.

Responsabilités

• Support on-time delivery and ensure quality from Fujifilm and EPCM providers.
• Review P&IDs and other process design documents.
• Write URSs and support FAT, CQV, and start-up activities.
• Provide on-floor manufacturing support and cross-train on unit operations.
• Collaborate with Quality, Manufacturing, Maintenance, Validation, and Safety departments.

Connaissances

Relationship building

Effective communication

Problem solving

Project management

Presentation skills

Formation

Bachelor’s degree in Chemical Engineering or Biotechnology Engineering or related field

Description du poste

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: https://www.fujifilm.com/us/en/about/region/careers

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.

Knowledge, Skills, and Abilities

• Ability to develop effective working relationships internally.
• Effective communication, both written and oral.
• Basic problem-solving skills.
• Basic project management skills.
• Ability to present information to others.

Minimum Qualifications

• Bachelor’s degree in Chemical Engineering, Biotechnology Engineering, or another related field.
• 0-1 years of engineering or other relevant technical work experience.

Preferred Qualifications

• Experience working in a cGMP environment or other highly regulated industry.
• Prior experience with mammalian cell culture processes.

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:

• Will work in environment which may necessitate respiratory protection.
• 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.

*LI-Onsite

EEO Information

Fujifilm 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.

ADA Information

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 ([e-mail]).