The Operator 1 position is responsible for the operation of equipment used in the filling and plating of Prepared Culture Media plates, bottle and tubes in a cGMP compliant manner. The individual will perform or assist in the setup, inspection, operation, preventive maintenance, troubleshooting and cleaning of equipment used throughout the Prepared Culture Media filling/bottling processes. The individual will be responsible for completing production batches and corresponding documentation.
The individual will also perform all ancillary tasks to support routine production, including area cleaning and 5S, movement of materials, AQL inspections, reworks, material reconciliation, and other tasks deemed necessary by production management.
SHIFT: Monday - Friday 10pm to 6:30am
Primary Duties:
Production
- Set-up, operate and troubleshoot as needed on various production machines for filling and high-speed packaging of Prepared Culture Media using HMI/SCADA interfaces.
- Operate a manufacturing process within controlled cleanrooms while meeting guidelines for production process flow.
- Perform equipment and component preparation tasks in non-controlled areas to meet batch processing timelines.
- Perform necessary calibrations and verifications of filling and packaging equipment.
- Execute production activities per approved Manufacturing Directions while maintaining compliance with all jorelated SOPs
- Perform ancillary cleaning and sanitization activities of production equipment and areas.
Quality
- Ensure that all batch documentation is completed in an accurate, thorough, and timely manner and in accordance with Good Documentation Practices.
- Perform in-process and AQL inspections to meet batch quality requirements.
- Provide assistance with the review and revision of Manufacturing Directions and SOPs necessary for the manufacture and packaging of product.
- Assist with manufacturing deviation analysis, CAPA actions, and other process equipment related quality concerns
- Maintain all work areas in a well-organized, clean and tidy manner at all times in accordance with the outlined 5S standards.
- Understand and follow aseptic practices to ensure safety and quality of the products.
Safety
- Comply with all OSHA and plant specific safety policies and procedures at all times, inform management of any safety hazards, and attend all required safety training.
- Appropriately use PPE (Personal Protection Equipment) as required to perform routine and non-routine duties.
Other Duties
- Collect accurate data for reports, charts and KPI's and interpret the data to identify problems and proceed with proper decision making.
- Accurately interpret technical documentation with high attention to detail.
- Assist with executing validation protocols associated with packaging equipment and procedures including revalidation as scheduled or required to maintain systems in a validated state
Qualifications:
- High School Diploma or GED required
- 2 years or more in a regulated production/operations environment
- Demonstrated proficiency in the operation of high speed, highly automated, production equipment preferred.
- Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) preferred.
- Knowledge of FDA and/or GMP regulations within production environment preferred.
- Ability to rapidly learn new procedures and reduce them to practice.
- Must be able to learn, comprehend and demonstrate competency in operating new equipment within a 90-day period of working with a trainer.
