Manufacturing Set Up Tech - 1st Shift

Benefits at bioMerieux:
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 $10,000 per calendar year
Onsite cafeteria with daily food stipend

Position Summary & Responsibilities:

The Manufacturing Set Up Technician position is responsible for the operation of high speed equipment used in the production and packaging of VITEK 2 in a cGMP compliant manner. The position may perform or assist in the setup, inspection, maintenance activities, troubleshooting and cleaning of equipment used throughout the VITEK 2 Manufacturing and Packaging processes.  The maintenance activities include all aspects of production maintenance work including lubricating, preventive maintenance, and repair of manufacturing/packaging process equipment along with corresponding documentation.  The position will require periodic infrastructure cleaning (maintain clean work environment), utilizing tools, cleaning chemicals along with the corresponding documentation.  Additionally, this individual will be responsible for completing production batches and corresponding documentation for the associated tasks, AQL inspections, reworks, and Material reconciliation that goes along with the batch. This is a working mentor position in which approximately 50% of this position is performing the duties of a Process Technician I/II/III and/or training others in the duties of a Process Technician I/II/III.  The position will assist in providing general work direction support and guidance at the direction of their group lead or management as needed.  Contribute to building a positive work environment.

• Execute production activities per approved Manufacturing Directions while maintaining compliance with all job related SOPs to support manufacturing, maintenance history records and training requirements. 
• Ensure all batch paperwork is completed in an accurate, thorough, and timely manner.
• Generate reports, charts and KPI's and interpret the data to identify problems, and proceed with proper decision making.
• Work with other departments and assist with executing validation protocols associated with manufacturing/packaging equipment and procedures including revalidation as scheduled or required to maintain systems in a validated state.
• Certified in operation of at least three high speed manufacturing equipment efficiently and effectively, in some cases highly automated, using HMI/SCADA interfaces.
• Provide assistance as necessary 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.
• Operate high speed manufacturing equipment, in some cases highly automated, using HMI/SCADA interfaces.
• Follow appropriate departmental cleaning procedures to ensure adequate cleaning of the manufacturing areas.
• Perform and document all processes and procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulations.
• 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.
• Assemble/disassemble processing equipment, clean manufacturing equipment parts, prepare bulk tubing kits and maintain daily use inventory. 
• Ensure clean stored equipment dates are compliant with SOP clean standards. 
• Perform self-audits in rooms and processes.
• Follow appropriate departmental cleaning procedures.
• Measure or weigh precise amounts of chemical ingredients using both automated and manual systems for dispensing per associated Manufacturing Directions.
• Operate and clean taping equipment, fill station, TIBLs, pouchers, cartoners and related systems in the manufacture of VITEK 2 manufacturing.
• Perform manual cleaning of all equipment, work areas, etc.
• Setup and assist others in the setup of high speed manufacturing equipment, vision systems, and barcoding equipment  within defined tolerances, to ensure product runs are started on time and within established guidelines.
• Leverage statistical process software to maintain optimal process centering and perform studies as needed.  Check equipment during production runs for proper performance and assures the group leader the line is maintaining standard speeds.  Recommend changes in equipment that would benefit line performance.
• Partner with maintenance staff to perform routine and Total Productive Maintenance (TPM) activities to include inspecting, lubricating, adjusting of manufacturing equipment in a timely basis to ensure reliability and minimize the incidence of unplanned downtime to production equipment.
• Perform other duties as assigned by Management.

Education, Skills, & Experience:

• High School Diploma/GED is required
  • 5+ years’ experience in FDA regulated manufacturing environment and GMP is desired
  • 5+ years’ experience maintaining and operating equipment is desired
• 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

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