Bio Process Associate

Spectraforce Technologies; Harvard (MA); On-site; USD 55,000 - 75,000; Full time

Job summary

Spectraforce Technologies in Devens, Massachusetts is seeking a Bio Process Associate for a 6-month assignment in biotechnology manufacturing. You will follow GMP and SOPs, operate upstream/downstream processes, and work in a cleanroom environment.

The role requires a high school diploma (Bachelor’s in science preferred), 1+ year GMP experience, strong attention to detail, and the ability to work weekend shifts on a rotating schedule with potential holidays.

Qualifications

• 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.

Responsibilities

• Performs routine manufacturing tasks per procedures, recognizing deviations from accepted practice.
• 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 Upstream/Downstream operations.
• Uses manufacturing automation systems including DeltaV, Syncade, OSI PI Historian and supporting systems.
• Ensures less experienced 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 with Quality representatives.
• Champions workplace safety initiatives.
• Supports continuous improvement initiatives for manufacturing processes, equipment and safety.

Skills

GMP knowledge

Attention to detail

Team collaboration

Documentation

Education

High School Diploma

Bachelor's degree in Science, Engineering, Biochemistry or related discipline preferred

Tools

DeltaV

Syncade

OSI PI Historian

Job description

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.