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Production Operator

2 months ago

Lombard, United States LanceSoft Full time

2 years minimum experience in manufacturing and machine operating experience. Not warehouse packaging. ** DO NOT SUBMIT CANDIDATES WHO ONLY HAVE MATERIAL HANDLING EXPERIENCE.

We are hiring for our 10pm - 6:30am shift (Monday - Friday)
The schedule is 8 x 5-hour days, with overtime anticipated.
Candidates must be available for overtime.

Position Summary:
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.
• Additionally, this individual will be responsible for completing production batches and corresponding documentation for the associated tasks. • 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.
Primary Duties:
1. 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 job-related SOPs
- Perform ancillary cleaning and sanitization activities of production equipment and areas.
2. 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.
3. 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.
4. 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
- Perform other duties as assigned by Management
Knowledge, Experience, and Skills:
- High School Diploma or GED
- Minimum of 2 years 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.
Other
1. Performs all job functions and responsibilities in a safe and responsible manner.
2. Ability to regularly climb stairs to perform work.
3. Ability to operate motorized pallet jacks.
4. May be exposed to and require the handling of chemicals, antibiotics and/or hazardous materials.
5. May be exposed to strong odors incurred during media production or other operations.
6. Job Duties are performed wearing various types of PPE and cGMP which include but are not limited to a hairnet, beard cover, safety glasses, safety shoes, hearing protection, gloves, PAPR, face mask and lab coat. Make-up and jewelry are prohibited in certain areas of Manufacturing.
7. Ability to maintain reliable and punctual attendance.
8. May be asked to cross train and support activities in other areas of production.
9. Ability to work overtime as required to support production operation.