LOCATION: Madison, WI
The Production Operator is responsible to manufacture bacterial cultures that meet or exceed company quality standards (cGMP) throughout the entire manufacturing process cycle. These activities include: Set up/Assembly, Bulk Fermentation Processing, Extraction, Filtration and Downstream Processing such as Drying and Milling.
To perform this job successfully, an individual must be able to perform each essential job duty. Essential job functions and duties include, but are not limited to:
- Operate process and utility equipment in a hygienic and safe manner in accordance with all processing procedures, cGMP, HAACP and SHE instructions and guidelines.
- Production equipment includes, but not limited to: Fermenters, Centrifuges, Heat Exchanges, Clean-in-Place (CIP) & Clean-out-of-place (COP) sanitation systems, homogenizers, blend tanks, freezers, scales, freeze dryers, mills, pelletizers, dishwashers and autoclaves.
- Required to perform Lock-Out, Tag Out, Try Out (LOTOTO) for equipment and follow all applicable permits.
- Monitor the status of the production process and control system. This may include, but not limited to, collecting samples for various analysis, recording data, making pH adjustments, identification of variances in raw materials, foreign debris, color changes, smell, moisture and temperature variations.
- Interpret data historian trends and control the process via the Human Machine Interfaces (HMI’s).
- Maintain accurate written records or logs of all production processes, cleaning or maintenance completed.
- Performs minor maintenance work (including operator lead preventative maintenance) on equipment when necessary to ensure continuous operation process. Manages work order requests through our electronic work order system.
- Follows all necessary standard operating procedures (SOP’s) and Work Instructions (WI’s). Assists with writing and updating SOP’s and WI’s as needed.
- Assist in maintaining all process areas within the manufacturing environment to comply with current regulatory guidelines and procedures.
- Participates in activities and initiatives for the following: Manufacturing Excellence, Continuous Improvement, Asset Health Management, Site Safety and Quality Programs, and Personal/Team Development.
The appropriate knowledge, skills and abilities required for this position are achievable through the following combination of education, work experience and training:
- High School Diploma (or equivalent)
- 2+ years of relevant experience in an FDA-regulated or controlled manufacturing environment; preferably industrial fermentation or pharmaceuticals.
- Knowledge in cGMP, inspection guidelines, sanitation, food regulations, and product safety.
Basic understanding of the purpose and contents within Safety Data Sheets (SDSs) and knowledge of various types of Personal Protective Equipment (PPE) available and the ability to properly wear the necessary PPE (as applicable).
- Basic mathematical skills and the ability to perform addition, subtraction, multiplication, division and conversions.
- Demonstrated Excel, Outlook, Word and general Microsoft office skills. The ability to be trained to use computers which will be required to monitor production status, enter data into various databases, review/retrieve SOP’s and WI’s and provide e-mail correspondence.
- Ability to work within established routines, methods and procedures under very strict parameters.
- Ability to work as a team player with a positive attitude. Hungry for success.
- Excellent communication skills; both written and verbal with the ability to read and comprehend English.
- Must be willing to work overtime, weekends, holidays, and varying shifts, as required.
- An associate’s degree or bachelor’s degree in industrial fermentation, processing technician, chemistry, microbiology, biology, food science or life sciences-related degree.
- Experience in a fermentation-based, food-grade manufacturing facility.
Operational understanding of the following processes: scale up and inoculation, fermentation, centrifugation, pelletizing, and CIP processes.
- Solid understanding of loop tuning and programming issues and ability to provide solutions.
- Advanced Microsoft office skills.
- Demonstrated self-learning skills.
- Previous experience with new-facility start up or new line/process start-up.
- Understanding and involvement in Overall Equipment Effectiveness (OEE) and continuous improvement process.
- Ability to repair or modify machinery, vehicles, or computers.