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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 yearsβ 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.