Production Technician
4 days ago
bioMerieux is seeking a highly skilled Production Technician to join our team. As a Production Technician, you will be responsible for the operation of high-speed equipment used in the production and packaging of VITEK 2 cards in a cGMP environment.
Key Responsibilities- Execute production activities per approved Manufacturing Directions while maintaining compliance with all job-related SOPs.
- Ensure that all batch paperwork is completed in an accurate, thorough, and timely manner.
- Execute validation protocols associated with manufacturing/packaging equipment and procedures, including revalidation as required to maintain systems in a validated state.
- Provide assistance with the review and revision of Manufacturing Directions and SOPs necessary for the manufacture and packaging of product.
- Certified in operation of at least one high-speed manufacturing equipment efficiently and effectively, in some cases highly automated, using HMI/SCADA interfaces.
- Engage in cage movement, maintain product segregation, retrieve and organize raw materials, and ability to learn fork truck operation.
- Follow appropriate departmental cleaning procedures to ensure adequate cleaning of the manufacturing areas.
- Setup high-speed manufacturing equipment, within defined tolerances, to ensure product runs are started on time and within established guidelines.
- Comply with all safety policies and procedures at all times.
- Appropriately use PPE (Personal Protection Equipment) as required to perform routine and non-routine duties.
- Maintain all work areas in a well-organized, clean, and tidy manner at all times in compliance with cGMP requirements.
- High School Diploma or GED required.
- 1-2 years' experience in FDA-regulated manufacturing environment and GMP is desired.
- Ability to express ideas clearly (verbal and written) with the ability to work from verbal and/or written instructions, manuals, work orders, and specifications.
- Ability to perform necessary calculations and complex task sequences in order to meet production requirements.
- Attention to detail and the ability to accurately interpret technical documentation are critical.
- Ability to perform computer applications, including learning and performing SAP transactions.
- Ability to routinely lift 20-50 pounds.
- Ability to stand for 8-12 hours.
- Ability to work overtime as required to cover a 24/7 operation.
- Extensive standing, repetitive hand and arm motions, ability to climb steps.
- Lifting (up to 50Lbs) and moving containers of cartons, tubes, and printed materials.
- Must be able to push a wheeled cage that can weigh up to 600 lbs fully loaded.
- Operating within cool temperature and low humidity conditions within the production room. Constant noise is common due to the operation of the air-dry chamber, taping, and pouching equipment.
- Excellent personal hygiene required.
- Appropriate gowning requirements necessary for the production areas. Gloves are required to handle the product. Hairnet, clean room gowns, and/or lab coats are required. Safety glasses and hearing protection are required personal protective gear.
- Occasional environmental odors may be prevalent.
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