Bio Process Associate

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 (i.e. bioreactors, media or buffer preparation equipment etc.).
• Trains for proficiency in process automation systems (i.e. Delta V and Syncade Interactions, OSI/Pi Historian) and some supporting business systems (i.e. SAP, Vault, Maximo etc.).
• Assist with the revision and or creation of process documents, such as SOPs and electronic work instructions.
• Assists in maintaining material and components inventory level.
• Supports safe work environment.

Qualifications and Requirements:

• 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.

Communication and Collaboration:

• Bioprocess Associates will work in teams and have continual interaction with members of his/her team as well as other bioprocess teams throughout the manufacturing process in order to exchange information regarding the batch(s) in process.
• In addition there will be frequent contact with members of the Quality department with regard to inline sampling and variance investigation.
• Lesser but also important are interactions with Materials Management and Maintenance staff for supplies and repair of equipment.
• All Bioprocess Associates/Specialists will have daily contact with her/his supervisory staff for work assignments, coaching and general management discussions.
• Occasional contact with other line management staff relating to specific project responsibilities may be expected.

Work Environment:

• Work is performed in a state-of-the-art large scale cell culture facility with classified areas requiring appropriate personal protective equipment (PPE).
• These roles require some contact with hazardous materials such as caustic, and steam.

Work Direction and Supervision:

• Works on assignments that are routine in nature where judgment is required in resolving problems and making routine recommendations.
• Incumbents normally receive general instructions on routine work and detailed instructions on new assignments.