Process Engineer 3

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 18 hours ago

Vacancies: 1 Vacancy

Department:

Engineering

Job Summary

Position Overview

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.

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

Serves as point of contact to the Engineering Procurement Construction Management (EPC) provider
Secures on time delivery and ensures quality from Fujifilm and EPCM provider for moderate complexity equipment packages
Develops and aligns moderate complexity plans and provides mitigations as needed
Reviews piping and instrumentation diagram (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 Acceptance Testing (FAT) 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 or assists with deviations change controls 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(s)
Participates in identifying 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

Basic Requirements

Bachelors degree in Chemical or Biotechnology Engineering or another related field with 5 years of Engineering or other relevant technical experience; or
Masters in Chemical or Biotechnology Engineering with 3 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)

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 processes

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Ability to ascend or descend ladders scaffolding ramps etc.
Ability to stand for prolonged periods of time
Ability to sit for prolonged periods of time
Ability to conduct activities using repetitive motions that include writs hands and/or fingers
Ability to operate machinery and/or power tools
Ability 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 motions

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:

Position OverviewThe 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...