Production Tech 1, Manufacturing - 3rd Shift

Description

Normal working hours for this position are 3rd Shift Sunday - Thursday from 10:00pm - 6:30am.

Position Summary:
The operation of high speed equipment used in the production and packaging of VITEK 2 cards in a cGMP environment. Perform or assist in setup, operation, inspection, maintenance, troubleshooting and cleaning equipment. Responsible for completing production batches and corresponding documentation, AQL inspections, reworks, and material reconciliation. Contribute to building a positive work environment.

• 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.
• Perform other duties as assigned by Management.

Education, Skills & Experience:

• 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.