Manufacturing Associate I (DS) 3rd shift
$54,080–$62,400 year
On-siteChicago, Illinois, United States
Job Summary
Execute upstream fermentation and downstream purification processes for microbial-based biosimilars in GMP cleanrooms, including media preparation, filtration operations, and chromatography column setup. Monitor product quality using PLC controls and in-process testing while maintaining accurate batch records and MES data entry. Perform daily cleaning routines, handle hazardous materials per EHS guidelines, and report nonconformances to the Supervisor. Support quality audits and regulatory inspections while troubleshooting equipment issues. Work the third shift (10:00 PM to 6:30 PM EST) with overtime eligibility and shift differentials.
Required Qualifications
- high school diploma
- 1-2 years of industry experience
- Must be able to move around the facility to reach various equipment
- Physical lifting and shifting required for pushing and pulling containers
- Must be able to lift at least 25 lbs
- Frequent moving of 25-50 lbs on carts
- Frequent moving of 100-200 lbs with assistance
- Must be able to stand for long periods of time
- Occasional bending, squatting, kneeling, stooping, pushing, pulling, reaching
- Frequent repetitive motions
- Must be able to understand and adhere to written and verbal instructions
- Ability to understand technical information, procedures, batch records, and other documents in English
- Ability to learn properly and efficiently using various hand and electrical tools
- Ability to work in a fast-paced environment and handle manufacturing demands and priorities
- The schedule is driven by process requirements
- The need for support of manufacturing activities may run through weekends or outside of normal shift hours
- Excellent interpersonal skills
- Effective communication with peers and supervision
- Reasoning Skills
- The ability to operate complex systems and equipment in accordance with current GMPs, SOPs, and safety guidelines under minimum supervision
- Basic skills for identifying problems and troubleshooting of the equipment and manufacturing processes
- Ability to work independently, within prescribed guidelines, or as a team member
- Demonstrated ability to follow detailed directions
- Basic computer skills, including Microsoft Word, Excel, and PowerPoint
- Operation and understanding of data management software
- Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc.
- Knowledge of GMP, GDP and safety requirements
- Knowledge of biotechnology operations such as Aseptic Filtration Systems, Aseptic Sampling, Filter Integrity Testing, Fermentation Process, Inoculation Process, Chromatography Columns, Mixing systems, Weigh Scales, etc.
- Manufacturing shift hours: Shift A (first shift): 06:00 AM to 2:30 PM EST, Shift B (first shift): 9:00 AM to 5:30 PM EST (first 14 days), Shift C (second shift): 2:00 PM to 10:30 PM EST, and Shift D (third shift): 10:00 PM to 6:30 PM EST
- Overtime (time and a half pay), holidays, and weekends will be required based on process requirements
- Candidates should currently reside within a reasonable commuting distance or be planning to relocate to the area
- Interviews and employment are conducted onsite at our Chicago, IL facility
Desired Qualifications
- Associate degree or higher in Biology, Chemistry, Biotechnology, or related
- Aseptic techniques and cleanroom manufacturing experience
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