MSAT Engineer - Operations

Overview

A rapidly growing biopharmaceutical manufacturing organization is seeking a MSAT Engineer to provide hands-on manufacturing operations support within a sterile fill/finish environment. This position will serve as a key on-the-floor technical resource supporting cleanroom manufacturing activities across formulation, prep, autoclave, and filling operations during critical production shifts.

Job Responsibilities

• Provide direct technical support to sterile manufacturing operations during weekend production shifts.
• Support cleanroom activities across formulation, prep, autoclave, and aseptic filling operations.
• Serve as an on-the-floor technical resource assisting operators and manufacturing personnel with process-related troubleshooting and operational support.
• Monitor manufacturing processes to ensure safe, compliant, and efficient execution within GMP environments.
• Assist with filter integrity understanding, process troubleshooting, equipment/process observations, and operational investigations.
• Partner cross-functionally with Quality, Manufacturing, MS&T, and Engineering teams to resolve production issues and improve operational performance.
• Support risk assessments, root cause analysis activities, and continuous improvement initiatives including FMEA methodologies.
• Participate in deviation support, though the primary focus of the role is hands-on manufacturing operations support rather than desk-based investigations.
• Provide strong communication and collaboration across multiple departments and production shifts.
• Maintain strong cleanroom presence, with the majority of the shift spent directly on the manufacturing floor.

Job Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related technical field preferred. Equivalent hands-on manufacturing experience without a degree will also be considered.
• 1–2+ years of experience supporting pharmaceutical, biopharmaceutical, or sterile manufacturing operations.
• Experience supporting aseptic processing, sterile fill/finish, formulation, filtration, autoclave, or GMP manufacturing operations preferred.
• Understanding of manufacturing investigations, operational troubleshooting, and process support within regulated environments.
• Familiarity with FMEA, root cause analysis, or continuous improvement methodologies preferred.
• Strong interpersonal communication and leadership potential with the ability to work cross-functionally on the manufacturing floor.
• Comfortable working extended periods standing within cleanroom manufacturing environments.