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Single Use Facility Bioprocess Associate

Summary:
The manufacturing bioprocess assists in the execution of clinical and commercial manufacturing processes in accordance to established standard operating procedures and production records for the manufacture of therapeutic proteins under current Good Manufacturing Practices (cGMPs).
Responsibilities:
1. Supports a safe work environment.
2. Works on routine manufacturing assignment per written procedures, where ability to recognize deviation from accepted practice is required.
3. Adheres to Good Manufacturing Practices and standard operating procedures.
4. Weighs and checks raw materials. Assembles, cleans and monitors equipment and processes.
5. Completes batch records and other quality regulated documentation under Good Documentation Practices (GDP) and all regulatory requirements.
6. Trains for proficiency in the operation of primary production equipment within the functional area such as chromatography skids, buffer preparation, weigh and dispense and TFF disposable skids.
7. Trains for proficiency in process automation systems (DeltaV, Syncade, PI Historian) and supporting business systems (SAP, Maximo).
8. Assist in the revision and creation of process documents, such as SOPs and MBRs.
9. Assists in maintaining material and components inventory level.
Skills/Knowledge:
High school diploma is required. Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is desired but not required.
Prior evidence of successful participation on work/study teams where combined contribution, collaboration, and results were expected.
Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web based applications.
Work/study experience where attention to detail and personal accountability were critical to success.
Demonstrates good interpersonal skills, is attentive and approachable.
Maintains a professional and productive relationship with area management and co-workers.



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