Manufacturing Engineer
4 weeks ago
- Monitor, optimize, and troubleshoot issues related to fermentation/cell culture or protein purification processes and unit operations.
- Perform product quality impact assessments and support root cause assessments for process discrepancies and Quality investigations.
- Identify and implement corrective actions, preventative actions, and continuous improvements for processes and equipment.
- Create, review, and revise cGMP documents such as batch records, SOPs, etc.
- Perform gap and technical assessments for global standards and procedures (GSPs and SOPs).
- Serve as risk lead or subject matter expert in support of risk assessments and hazards analysis, e.g., microbial control risk assessments.
- Develop technical training material and conduct technical training for production staff.
- Support the technology transfer of new products/processes, e.g., perform field testing.
- Create, review, revise, and approve technical reports and engineering documents such as URS, FS, SDS, P&IDs, etc.
- Design, procure, commission, and qualify new equipment.
- Work effectively as part of a team responsible for ensuring successful and efficient processes to produce recombinant proteins.
- Serve as subject matter expert for regulatory inspections as well as internal audits and support inspection response.
- Collaborate with multidisciplinary teams to achieve project objectives.
- Assist in experimental design and troubleshooting as needed.
- Bachelor's degree in a relevant life science field (e.g., biology, biotechnology, biochemistry).
- Previous experience in a GMP environment is preferred.
- Strong attention to detail, organizational skills, and the ability to work independently or in a team.
- Excellent communication skills, both written and verbal, in English.
- Adherence to safety protocols and regulatory compliance.
- Compliance with cGMP and site safety & security regulations at all times.
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