Bio Process Associate - 1st Shift

Job Title: Bio-Process Associate

Location: Devens, MA 01434 - 100% onsite

Duration: 6 Months

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

Required to work on holidays and weekends as scheduled

Must Haves:

• Strong knowledge of either upstream and/or downstream unit operation is essential.
• 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, spreadsheets, and web-based applications.
• Previous work experience where attention to detail and personal accountability were critical to success

Key Responsibilities:

• Works on routine manufacturing assignments 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 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.
• Operates all production equipment within the assigned functional area (i.e. Upstream: Media formulation equipment, glass washers, dispensary, bioreactors, harvest equipments 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 Standard 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 a culture of continual improvement through ownership of improvements to work processes, equipment, and the safe work environment.

Qualifications & Experience:

• 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 1 + 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 and co-workers

Contact:

Sunny Rajput | sunny.r@sunrisesys.com | URL: www.sunrisesys.com