Process Engineer 1
On-siteHolly Springs, North Carolina, United States
Job Summary
Support on-time delivery and ensure quality from Fujifilm and Engineering, Procurement, Construction Management (EPCM) provider by reviewing piping and instrumentation diagram (P&IDs) and other process design documents. Provide input to detailed design activities, write User Requirement Specifications (URSs), and support Factory Acceptance Testing, Commissioning Qualification, and Validation with supervision. Serve as on-call support for process equipment, review and approve technical documents, and contribute to system impact and quality risk assessments. Support technology transfer activities, execute Good Manufacturing Practices (GMP) runs, and provide technical support for root cause analysis and process deviation investigations. Assist with deviations, change controls, and corrective and preventive action closures while collaborating with Quality, Manufacturing, Maintenance, Validation, and Safety departments.
Required Qualifications
- Bachelor's degree in Chemical Engineering, Biotechnology Engineering, or another related field
- 0-1 years of engineering or other relevant technical work experience
Desired Qualifications
- Experience working in a cGMP environment or other highly regulated industry
- Prior experience with mammalian cell culture processes
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