Packaging Set Up Tech - Day Shift

Description

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 normal working hours for this role are day shift working 7:00am - 7:30pm working a 2-2-3 rotation.

The Manufacturing Set Up Technician position is responsible for the operation of high speed equipment used in the production and packaging of BacT/ALERT bottles and/or preparing and formulating the liquid reagents that fill the finished BacT/ALERT bottle 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 BacT/ALERT 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. 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.

• Maintenance
  • Partner with maintenance staff to perform routine and Total Preventative 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.
  • Use standard mechanics tools including drill press, vise and bench grinder as necessary to service all manufacturing equipment.
  • Read and interpret Blue Prints and Schematic Drawings.
  • Perform Maintenance Focused Math and Measurements
• Production
  • Operate and maintain highly automated bottle handling, filling, vision inspection, conveying, robotic palletizing, autoclaving, labeling and / or process batching equipment in a cGMP compliant manner, using HMI/SCADA interfaces
  • Setup high speed manufacturing equipment, vision systems and barcoding equipment within defined tolerances, to ensure product runs are started on time and within established guidelines
  • Check equipment during production runs for proper performance and assures the group leader the line is maintaining standard speeds
  • Troubleshoot moderate equipment related issues
  • Execute production activities per approved Manufacturing Directions while maintaining compliance with all job related SOPs to support manufacturing, maintenance history records and training requirements.
• Quality
  • Ensure that all batch paperwork is completed in an accurate, thorough, and timely manner
  • Perform and document all processes and procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulations
  • Perform technical writing as it relates to Preventive Maintenance SOPs and Training SOPs and Technical Documentation
  • 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 compliance with cGMP requirements
  • Operate equipment, utilize SOP and documentation to record data manually or through identified software applications.
  • Perform self-audit of rooms and processes
  • Train and certify teammates on production processes and procedures
• Safety
  • 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.
• Other Duties
  • 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
  • Attention to detail and the ability to accurately interpret technical documentation are critical
  • Perform computer applications including learning and execution of SAP transactions
  • Leverage statistical process software to maintain optimal process centering.
  • Communicate with Materials Management, Production Operations, and Quality Control on a daily basis to ensure the timely and efficient production of all of our customer requirements
  • Serves a back up to the Supervisor (or higher) when needed
  • Perform other duties as assigned by Management

Education, Skills and Experience:

• High School Diploma or GED with 3 years in a production environment with demonstrated maintenance and repair aptitude OR 2 years maintenance and repair & 2 years in production environment.
  • Associate Degree in an applicable or Technical field or Vocational / Technical School with 2 years experience production environment and/or maintenance & repair also accepted
• Electromechanical background preferred
• 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.) and ISO preferred.
• Knowledge of FDA and/or GMP regulations preferred.
• Must be able to learn, comprehend and demonstrate competency in operating new equipment within a 75-day period of working with a trainer.
• Attention to detail and the ability to accurately interpret technical documentation

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