Process Engineer 2, Visual Inspection

Full-time

FUJIFILM Biotechnologies

Position Overview
The Process Engineer 2 that supports Drug Product Finished Goods (DPFG) within the assigned area(s) [Visual Inspection] provides engineering guidance to stakeholders throughout the organization to support capital projects, technology transfer, and manufacturing operations while ensuring processes are efficient, scalable, compliant with Current Good Manufacturing Practice (CGMP) regulations. This role adheres to product and customer requirements and works toward optimizing plant efficiency and reliability. This role also utilizes their experience with automated systems related to inspection of pharmaceutical products and camera and vision-based inspection systems.
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:
Job Description
What You'll Do:
Serves as point of contact to the Engineering, Procurement, Construction Management (EPCM) provider
Secures on time delivery and ensures quality from Fujifilm EPCM provider for equipment packages with limited complexity
Develops and aligns basic 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 Requirements 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 with limited supervision
Performs 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
Supports continuous improvement projects in partnership with Maintenance and Manufacturing
Cross-trains on multiple 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
Minimum Requirements:
Bachelor's degree in Chemical or Biotechnology Engineering, or another related field with 2 years of Engineering experience; or
Master's degree in Chemical or Biotechnology Engineering with no prior experience
Experience in a Life Science or other regulated industry
Experience with Engineering drawings and using 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
Prior experience with mammalian cell culture processes
EEO Information
Fujifilm 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 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 (View email address on us.fitly.work).

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Vacancy posted a month ago

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