Process Engineer I, Drug Product

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 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70000 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: Description

What Youll 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

• Bachelors 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.

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 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 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 ().

Required Experience:

IC