Process Engineer 3
4 weeks ago
This position reports to the Process Engineering Manager, Downstream in support of the Process Equipment team. The initial assignment is to assume the Responsible Engineer role for Buffer Prep unit operations.
As the site moves into commercial operations, this position is planned to continue as primary support for Buffer Prep unit operations, with secondary responsibility expanding to cover additional Downstream unit operations.
Key responsibilities include:
- Serving as point of contact to 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
- Reviewing, redlining, and approving P&IDs and other technical documents as the technical authority
- Leading system impact assessments and quality risk assessments for process equipment
- Performing technology transfer (TT) activities related to process equipment
- Supporting execution of Good Manufacturing Practices (GMP) runs
- Providing technical support for root cause analysis (RCA) and process deviation investigations
- Leading or assisting with deviations, change controls, and corrective and preventive action (CAPA) closures
- Making decisions regarding technical risk assessments for new manufacturing equipment
- Providing on-floor manufacturing support for equipment issues
- Providing process equipment training and consultation on topics within assigned area(s)
- Participating in identifying continuous improvement projects within unit operations, in partnership with Manufacturing when applicable, to improve manufacturability, reliability, yield, and cost
- Supporting supplier technical evaluations, risk assessments, and equipment evaluation and qualification
- Conducting training and presenting information to team or other stakeholders
- Cross-training on unit operations to assist team with achieving deliverables
- Collaborating with other departments, such as Quality, Manufacturing, Process Science, Maintenance, and Automation
Basic requirements include:
- 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 include:
- 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
FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identity, or any other protected class.
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