The Bioprocess Specialist is responsible for 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).
Works on routine manufacturing per written procedures that are complex with on instructions, where ability to recognize deviation from accepted practice is required.
Adheres to Good Manufacturing Practices and standard operation 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.
Operates all production equipment within the assigned functional area (i.e. Upstream: Media formulation equipment, glass washers, dispensary, bioreactors, harvest equipment or Downstream: Buffer equipment, glass washers, chromatography skids, membrane operations, column packing skids, etc.)
Effectively uses process automation systems (i.e. Delta V and Syncade Interactions, OSI/Pi Historian) and some supporting business systems (i.e. SAP, Trackwise, Maximo etc)
Ensures less experienced manufacturing personnel comply with Stand Operating Procedures (SOPs) and electronic work instructions.
Assists with the coordination and implementation of special projects such as validation or complex investigations.
Revises and creates process documents with no instructions, supports routine process investigations.
Assists with reviewing batch and exception reports for each manufacturing lot in conjunction with Quality representative.
Champions areas specific initiatives associated with work safety.
Engages in and supports culture of continual improvement through ownership of improvement for work processes, equipment and safe work environment.
Knowledge and Skill:
- 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.
- A minimum of 5+ years process operations experience in a highly automated biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations.
- Strong knowledge of either upstream and/or downstream unit operation is essential.
- Practical knowledge of regulations such as GMP and company Standard Operating Procedures (SOP).
- Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected.
- Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web based applications.
- Previous work 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
Apply here: https://express.cand...rd/63773653bc56