Bioprocess Associate (1st shift) (Onsite- Devens, MA)

Bioprocess Associate (1st Shift) (Onsite- Devens, MA)

We are seeking a Bioprocess Associate for a global pharmaceutical client. The focus of the role is to assist in the execution of commercial manufacturing processes in accordance with current Good Manufacturing Practices (cGMPs).

This is a 40-hour per-week, 6-month contract (extensions possible), 100% onsite role at client s office in Devens, MA. 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

This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.

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 culture of continual improvement through ownership of improvement for work processes, equipment and safe work environment.
  
  

Requirements

• 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.
• 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.
  
  

Please submit your resume to our network at https://www.stage4solutions.com/careers/ (please apply to the Bioprocess Associate (1st Shift) (Onsite, Devens, MA) role).

Please feel free to forward this project opening to others who may be interested.

Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.

Compensation: $28/hr. - $30.67/hr.