Senior Manufacturing Associate

TSR Consulting, Inc.; Harvard (MA); On-site; USD 37,000 - 51,000; Full time

Job summary

TSR Consulting, Inc. is currently seeking a Bio Process Associate – 2nd Shift for an opportunity in Devens, MA.

The role supports manufacturing operations in a large-scale cell culture environment, requiring experience in cGMP settings and adherence to SOPs. The candidate will work 5:00 PM – 5:00 AM on a 3-month contract with potential extension, onsite only, and will operate production equipment, document processes, and maintain cleanroom standards while collaborating with Manufacturing,

Qualifications

• High school diploma or equivalent required.
• Experience in a manufacturing environment; cGMP experience preferred.
• Familiarity with electronic documentation systems.
• Ability to use hand tools and perform equipment assembly and cleaning.

Responsibilities

• Perform routine manufacturing activities according to approved procedures and recognize deviations from standard practices.
• Follow current Good Manufacturing Practices (cGMP), SOPs, and applicable safety requirements.
• Weigh and verify raw materials and assist with equipment assembly, cleaning, and sterilization.
• Monitor in-process manufacturing operations and complete electronic work instructions accurately.
• Train to operate production equipment, including bioreactors and media/buffer preparation systems.
• Use computer-based manufacturing systems and applications, including DeltaV, Syncade, OSI/PI Historian, SAP, Vault, and Maximo.
• Assist with creating and updating SOPs and electronic work instructions.
• Support inventory control and ensure materials and components are available for production.
• Maintain cleanroom standards, follow proper PPE requirements, and promote a safe working environment.
• Collaborate with Manufacturing, Quality, Materials Management, and Maintenance teams to support production activities.

Skills

Manufacturing experience

cGMP knowledge

SOP compliance

Detail-oriented

Teamwork

Onsite readiness

Education

High school diploma or equivalent

Tools

DeltaV

Syncade

OSI/PI Historian

SAP

Vault

Maximo

Job description

Duration: 3 months + potential to extend

Pay Rate: $27–$37/hour (W2) + shift differential

Work Arrangement: 100% Onsite

Shift: 5:00 PM – 5:00 AM

About the Role

TSR Consulting is currently seeking a Bio Process Associate – 2nd Shift for an opportunity in Devens, MA. This role will support manufacturing operations in a large-scale cell culture environment. The ideal candidate will have experience working in a manufacturing or cGMP environment, following standard operating procedures, handling process equipment, and maintaining accurate production documentation.

Key Responsibilities

• Perform routine manufacturing activities according to approved procedures and recognize deviations from standard practices.
• Follow current Good Manufacturing Practices (cGMP), SOPs, and applicable safety requirements.
• Weigh and verify raw materials and assist with equipment assembly, cleaning, and sterilization.
• Monitor in-process manufacturing operations and complete electronic work instructions accurately.
• Train to operate production equipment, including bioreactors and media/buffer preparation systems.
• Use computer-based manufacturing systems and applications, including DeltaV, Syncade, OSI/PI Historian, SAP, Vault, and Maximo.
• Assist with creating and updating SOPs and electronic work instructions.
• Support inventory control and ensure materials and components are available for production.
• Maintain cleanroom standards, follow proper PPE requirements, and promote a safe working environment.
• Collaborate with Manufacturing, Quality, Materials Management, and Maintenance teams to support production activities.

Required Qualifications

• High school diploma or equivalent required.
• Experience in a manufacturing environment; commercial manufacturing experience is preferred.
• Familiarity with cGMP requirements and following SOPs.
• Basic computer skills and experience with electronic documentation systems.
• Ability to use hand tools and perform equipment assembly and cleaning activities.
• Strong attention to detail, accountability, and problem-solving skills.
• Good communication and teamwork skills.
• Ability to work onsite in a cleanroom environment and follow all safety and PPE requirements.

Preferred Qualifications

• Experience in biopharmaceutical manufacturing, biologics production, or large-scale cell culture.
• Exposure to manufacturing systems such as DeltaV, Syncade, OSI/PI Historian, SAP, Vault, or Maximo.
• Experience with batch documentation, raw material handling, equipment preparation, or in-process monitoring.

Work Schedule

This position follows a rotating 12-hour shift schedule from 5:00 PM to 5:00 AM.

• 3 days on: Saturday, Sunday, Monday
• 2 days off: Tuesday, Wednesday
• 2 days on: Thursday, Friday
• 3 days off: Saturday, Sunday, Monday

Please note: This is a 100% onsite position in Devens, MA. The role involves working in classified cleanroom areas, wearing required PPE, and handling process materials that may include caustics and steam.

About TSR Consulting

TSR Consulting is a trusted staffing and workforce solutions partner with more than 50 years of experience supporting clients' critical business and technology initiatives. We connect qualified professionals with opportunities across leading organizations.

In June 2024, TSR was acquired by Justin Christian, founder and CEO of BCforward, expanding our capabilities and opportunities for clients and consultants.