Biotechnology Engineer
4 days ago
Job Overview
FUJIFILM Diosynth Biotechnologies is seeking an experienced Biotechnology Engineer to join our team in Holly Springs, NC. As a key member of our Process Engineering department, you will be responsible for designing and implementing process improvements to enhance the efficiency and quality of our Life Science manufacturing operations.
About the Role
This position will report to the Process Engineering Manager and will be responsible for:
- Serving as the point of contact for the Engineering, Procurement, Construction Management (EPC) provider
- Securing on-time delivery and ensuring quality from Fujifilm and EPCM provider for moderate complexity equipment packages
- Developing and aligning moderate complexity plans and providing mitigations as needed
- Reviewing piping and instrumentation diagram (P&IDs) and other process design documents
- Providing direction to detailed design activities in partnership with the EPCM provider
- Writing User Requirement Specifications (URSs)
- Supporting Factory Acceptance Testing (FAT), Commissioning Qualification and Validation (CQV), and start-up activities
- Serving 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
Requirements
To be considered for this role, you must have:
- Bachelor's degree in Chemical or Biotechnology Engineering, or another related field with 5 years of Engineering or other relevant technical experience; or Master's 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 harvest unit operations (Centrifugation, Filtration) in a pharmaceutical or Life Science environment; Experience with mammalian cell culture processes.
Salary Information
The estimated annual salary for this position is $95,000-$110,000 depending on experience.
About FUJIFILM Corporation
At FUJIFILM Diosynth Biotechnologies, we are committed to delivering innovative solutions that transform lives. Our state-of-the-art Life Science manufacturing facility in Holly Springs, NC, is one of the largest in North America. We offer a dynamic work environment, competitive compensation, and opportunities for professional growth and development.
EEO Statement
FUJIFILM Diosynth Biotechnologies is an equal opportunity employer. We welcome applications from diverse candidates who share our commitment to excellence and innovation.
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