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Process Engineer
3 months ago
Job Title: Engineering - Process Engineer
Key Responsibilities:
- Documentation & Reporting: Develop and author study protocols and technical reports. Revise process documents as necessary to support technology transfer and implement process changes.
- Process Monitoring: Perform and support data monitoring of manufacturing processes to assess and understand process capability.
- Production Support: Assist in production-related investigations, ensuring compliance with internal standards and regulatory requirements.
- Batch Record Review: Review executed batch records to ensure processes are operating within validated states.
- Tool Management: Understand and manage tools and templates for quantifying the impact and criticality of parameters and attributes within BMS and/or CMO unit operations.
- Process Control: Ensure manufacturing processes are consistently controlled and harmonized across the cell therapy network.
- Continuous Improvement: Support continuous improvement initiatives for both technical and business processes.
- External Collaboration: Leverage and maintain professional relationships with external partners to enhance process efficiency and effectiveness.
Desired Background and Experience:
- Education: B.S. or M.S. in Biochemical, Chemical, or Biomedical Engineering, or a related field such as Cell Biology/Immunology. (PhD candidates may be considered overqualified)
- Industry Experience: 4-7 years of relevant experience, with a strong preference for experience in cellular therapies and regulated manufacturing environments.
- Technical Skills: Proficiency in MS Office (4+ years) is required; experience with JMP is preferred.
- Flexibility: Ability to work across East Coast and West Coast time zones.
- Communication & Teamwork: Excellent communication, writing, organizational, and presentation skills. Strong interpersonal skills for effective collaboration with cross-functional teams and external partners.
