Bio Process Associate 2nd shift

Work Schedule

Shift: 5pm–5am. Shift rotation: 3 days on (Sat, Sun, Mon), 2 days off (Tues, Wed), 2 days on (Thurs, Fri), 3 days off (Sat–Mon). Must be flexible to work on holidays.

About the role

The Bioprocess Associate/Specialist assists in the execution of commercial manufacturing processes according to established electronic work instructions and production records for the manufacture of therapeutic proteins in accordance with current Good Manufacturing Practices (cGMPs).

Responsibilities

• Works on routine manufacturing assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Adheres to Good Manufacturing Practices and standard operating procedures.
• Weighs and checks raw materials.
• Assembles, cleans, and sterilizes process equipment; monitors processes.
• Completes electronic work instructions and maintains clean room environment to comply with regulatory requirements.
• Trains for proficiency in the operation of primary production equipment within the assigned functional area (e.g., bioreactors, chromatography skids, media or buffer preparation equipment).
• Trains for proficiency in process automation systems (e.g., Delta V and Syncade Interactions, Pi Vision) and some supporting business systems (e.g., SAP, Infinity, Maximo).
• Assists with the revision and/or creation of process documents, such as SOPs and electronic work instructions.
• Assists in maintaining material and components inventory levels.
• Supports a safe work environment.

Requirements

• High school diploma is required.
• 1+ years of experience in a GMP environment.
• Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline 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.

Work Environment & Interactions

Bioprocess Associates work in teams and have continual interaction with members of their team as well as other bioprocess teams throughout the manufacturing process to exchange information regarding the batch(s) in process. There is frequent contact with members of the Quality department regarding inline sampling and variance investigation, and with Materials Management and Maintenance staff for supplies and equipment repair. Daily contact with supervisory staff for work assignments, coaching, and general management discussions is expected, with occasional contact with other line management staff relating to specific project responsibilities.