Manufacturing Associate

Job Description: 100% onsite required

Work Schedule: Shift: 5pm- 5am (Night Shift)

Shift rotation: 3 days on (Sat, Sun, Mon), 2 days off (Tues, Wed), 2 days on (Thurs, Fri), 3 days off (Sat to Mon).

Must be flexible to work on holidays

Required 1+ years of experience in GMP environment

Principle Objective of position:

• 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).

Job 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, chromatography skids, media or buffer preparation equipment etc.).
• Trains for proficiency in process automation systems (i.e. Delta V and Syncade Interactions, Pi Vision) and some supporting business systems (i.e. SAP, Infinity, 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.

Education:

• 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.
• 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.