Bio Process Associate

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.

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.

• 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.

• 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.

• Laboratory environment.
• No blood or animal handling.
• Position handles hazardous materials.
• Cleanroom manufacturing environment.
• Weekend and holiday work required.