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Manufacturing Process Specialist
2 months ago
As a Process Engineer, your main duties will encompass:
- Drafting study protocols and technical documentation, along with updating process records as necessary to facilitate technology transfer and modifications in processes.
- Conducting and assisting in the monitoring of manufacturing operations to assess process capabilities.
- Aiding in production-related inquiries, ensuring adherence to internal protocols and regulatory standards.
- Evaluating completed batch records to confirm that processes are functioning within validated parameters.
- Comprehending and overseeing tools and templates designed to assess the impact and significance of parameters and attributes within Client and/or CMO unit operations.
- Guaranteeing that manufacturing processes are consistently controlled and standardized across the cell therapy network.- Promoting ongoing enhancements for both technical and operational processes.
- Cultivating and sustaining professional relationships with external collaborators.
Preferred Qualifications:
- B.S. or M.S. degree with 4-7 years of pertinent experience in Biochemical, Chemical, or Biomedical Engineering, or a discipline related to Cell Biology/Immunology. (PhD candidates may be considered overqualified)
- Experience in cellular therapies is strongly preferred.
- Proficiency in MS Office for over 4 years, with familiarity in JMP being advantageous.
- More than 4 years of experience in a regulated manufacturing setting is highly desirable.
- At least 1 year of experience in technical documentation or deviation reporting.
- Willingness to work across various time zones.
- Strong communication, writing, organizational, teamwork, and presentation skills.
- Outstanding interpersonal abilities to collaborate with teams across different functions and organizations.
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