Process Development Engineer
6 days ago
We are seeking a highly skilled Process Development Engineer to join our team at ACL Digital. As a Process Development Engineer, you will play a critical role in the development and implementation of new processes and technologies to support the production of high-quality biopharmaceuticals.
Key Responsibilities:
- Transfer purification drug substance processes and perform process improvements from the laboratory into the manufacturing facility
- Provide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation
- Offer process validation support for late stage commercial processes
- Provide routine process monitoring and troubleshooting
- Execute data trending and statistical process analysis
- Support technical direction for process related deviations, CAPAs and change controls
- Identify and support process related operational excellence opportunities
Requirements:
- Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
- Top 3 Must Have Skill Sets: Cell Culture and/or Purification experience, manufacturing experience, engineering experience
- Experience with technical trouble shooting skills
- STRONG communication - must be comfortable speaking to a group of 20+ manufacturing associates in presentation (data reviews/etc.)
- GMP experience highly preferred (Looking for GMP background/ someone who has dealt with FDA/ inspectors/ auditors)
What We Offer:
- A dynamic and innovative work environment
- Opportunities for professional growth and development
- A competitive salary and benefits package
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