Instil Bio is seeking a driven and experienced Senior Process Engineer to support Clinical Manufacturing facility start-up and production activities. The Senior Process Engineer will lead or support technology transfers, root cause investigations, impact assessments, process improvements, and process monitoring. The successful candidate should be detail oriented and enjoy working in a dynamic high-paced environment to deliver innovative therapies to patients in need.
Responsibilities:
- Review and revise batch records and sample plans; author and review technical documents in support of process changes
- Draft impact assessments in support of deviations and change controls
- Lead process improvement initiatives involving cross-functional teams including Manufacturing, Quality, Process Science & Engineering, and Facilities & Engineering
- Perform risk assessments and investigations including root cause analysis utilizing a systematic approach and industry best practices
- Determine corrective and preventative actions for process-related deviations
- Support technology transfers and execution of verification runs including person-in-plant (PIP) support
- Build and maintain process data monitoring for clinical manufacturing
- Support regulatory filings and facility startup as needed
- Support process FMEA
Requirements:
- Bachelor’s degree, in life sciences, engineering or related field and 5 or more years of industry experience; Masters degree with 3 or more years of experience; PhD and 0-2 years of experience
- Enjoy working in a fast-paced environment
- Experience in cell or gene therapies preferred