Manufacturing Associate II Downstream Purification | Just Evotec
Overview
As a Manufacturing Associate II in Downstream Purification, you will execute cGMP biotherapeutics production at commercial scale, owning single-use bioreactor operations, chromatography, and product filtration on a Day shift (Sun-Wed, 7am-6pm). You'll operate MES systems, initiate non-conformances, and support new product introductions. This site-based role in Redmond, WA demands precision and curiosity, offering direct impact on worldwide biotherapeutic access.
What You'll Do9
- 1Execute single-use bioreactor operations, perfusion, chromatography, and product filtration per batch records, ensuring right-first-time performance.
- 2Support new product and technology introductions into the facility, collaborating with process development teams.
- 3Initiate non-conformances (NC) and document deviations in the MES system, driving root cause analysis.
- 4Draft and revise Manufacturing Procedures and Standard Operating Procedures (SOPs) to improve process consistency.
- 5Operate glasswasher and autoclave, maintaining equipment cleanliness and sterility.
- 6Prepare media and buffer solutions, verifying pH, conductivity, and bioburden per specifications.
- 7Monitor equipment parameters and perform in-process sampling, escalating anomalies promptly.
- 8Complete Electronic Batch Records (EBR) using MES to maintain data integrity and traceability.
- 9Participate in continuous improvement initiatives to enhance yield and reduce cycle time.
Requirements7
- 1Bachelor's degree in Science or Engineering; or Associate's degree in a science-related field with relevant experience; or High school diploma/GED and 3+ years in Manufacturing or Pharma.
- 21+ years hands-on experience in cGMP biopharmaceutical manufacturing, preferably in downstream processing.
- 3Proficiency with MES (e.g., PAS-X) and electronic batch records.
- 4Strong attention to detail with a right-first-time mindset in documentation and execution.
- 5Ability to troubleshoot technical issues of moderate scope in chromatography or filtration systems.
- 6Effective task/time management to handle multiple priorities in a 24/7 production environment.
- 7Excellent oral and written communication for cross-functional collaboration and documentation.
Salary Insight
$67 - $75k per year
Location
Required Skills
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