Position Title:

Bio Process Associate Work Location:

Devens, Massachusetts Assignment Duration:

06

Months Work Schedule:

Shift rotation: 3 days on (Saturday, Sunday, Monday) 2 days off (Tuesday, Wednesday) 2 days on (Thursday, Friday) 3 days off (Saturday-Monday) Required to work weekends and holidays as scheduled. Position Summary Works on routine manufacturing assignments following written procedures within a biotechnology manufacturing environment while complying with Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and regulatory requirements. 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 manufacturing processes. Completes electronic work instructions. Maintains cleanroom environment to comply with regulatory requirements. Operates production equipment within assigned functional area including Upstream and Downstream operations. Uses manufacturing automation systems including DeltaV, Syncade, OSI PI Historian and supporting business systems. Ensures less experienced manufacturing personnel comply with SOPs and electronic work instructions. Assists with validation activities and complex investigations. Revises and creates manufacturing process documentation. Supports routine manufacturing investigations. Reviews batch and exception reports alongside Quality representatives. Champions workplace safety initiatives. Supports continuous improvement initiatives for manufacturing processes, equipment and safety. Qualifications & Experience High School Diploma required. Bachelor's degree in Science, Engineering, Biochemistry or related discipline preferred but not required. Minimum 1+ year process operations experience within a GMP biotechnology manufacturing facility. Strong knowledge of Upstream and/or Downstream manufacturing operations. Working knowledge of GMP regulations. Working knowledge of Standard Operating Procedures. Experience working effectively in collaborative manufacturing teams. Strong computer proficiency including Microsoft Office and web-based applications. Strong attention to detail. Demonstrated personal accountability. Good interpersonal skills. Professional working relationship with management and coworkers. Working Conditions Laboratory environment. No blood or animal handling. Position handles hazardous materials. Cleanroom manufacturing environment. Weekend and holiday work required.