2nd Shift Manufacturing Operator (BioServices)

Role Summary

2nd Shift Manufacturing Operator (BioServices) supporting biopharmaceutical bulk products production with emphasis on safety, quality, and manufacturing performance in Cell Culture, Purification, or BioServices areas. Operates within PLC/HMI-controlled processes, adheres to cGMP standards, and contributes to process execution and documentation.

Responsibilities

• Prepare and operate equipment according to written procedures, including setup/sterilization of components and process equipment, monitor parameters, adjust operational settings, perform in-process sampling, and conduct routine assays.
• Provide process-team support per MSOE 602; record data, log activities, and monitor processes; assist in troubleshooting and general maintenance.
• Review batch records for completeness and accuracy; author or revise SOPs and batch records; participate in non-conformance investigations and change controls as needed.
• Train and coach junior/new operators; maintain high safety awareness and communicate safety issues promptly; adhere to PPE and all safety, environmental, quality, and EEO/AA standards.
• Perform duties with honesty and integrity.

Qualifications

• Minimum of 2 years of relevant experience; ability to understand technical nomenclature and mathematical formulas.
• Strong manual dexterity, mechanical aptitude, and ability to follow detailed instructions with clear, accurate documentation.
• Excellent communication, interpersonal, and written skills; knowledge and experience in aseptic processing techniques; ability to apply technical experience to problem solving.
• Physical requirements: lift up to 50 pounds; bend, reach, stretch, climb ladders, work in tight spaces; stand for long periods; wear cleanroom attire.

Education

• Minimum HS degree with 2-4 years‚Äô work experience (B1). BA/BS in biology, chemistry, or related discipline, or equivalent work experience (B2/B3).

Additional Requirements

• This is a 2nd shift position: Wednesday - Saturday, 2:00pm - 12:30am. Travel not required. Lifting required 50 pounds. On-call may be required. Shift work may apply.