Description

Benefits at bioMerieux:

• Sign on bonus of $1200
• Low-cost medical, dental, and vision benefits starting day one
• 11 paid holidays
• 160 hours of paid time off
• Annual bonus
• 9.5% 401k company contribution with no vesting period
• Tuition reimbursement up to $10000 per calendar year
• Onsite cafeteria with daily food stipend
• Starting pay is $17-19/hr. depending upon experience. Shift differential pay for nights and weekends.

• 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.

Position 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.
• Perform other duties as assigned by Management.

Position 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.