Senior Process Engineer
4 weeks ago
Job Summary
This position reports to the Director of Process Engineering in support of the Process Equipment team. The successful candidate will support the Aura project, a greenfield expansion construction project in Holly Springs, NC. The initial assignment will be to assume the Responsible Engineer role for the Product Hold unit operation.
Key Responsibilities
- Serves as point of contact to the Engineering, Procurement, Construction Management (EPCM) provider for high complexity equipment packages
- Ensures on-time delivery and quality from Fujifilm and EPC provider for high complexity equipment packages
- Develops and aligns high complexity 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 Requirement Specifications (URSs)
- Supports Factory Assessment Tests (FATs), 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 deviation 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
- Identifies 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
- Bachelor's degree in Chemical or Biotechnology Engineering, or another related field with 8 years of Engineering or other relevant technical experience; or
- Master's degree in Chemical or Biotechnology Engineering with 6 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)
- Proficient experience in multiple unit operations within the assigned plant section
Preferred Requirements
- Prior experience working in a cGMP environment or other highly regulated industry
- Experience with large scale mammalian cell culture processes, ≥ 2000L
- Large scale capital project experience, > $500M USD
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