Manufacturing Tech I, Service - 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:

The Process 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, preventive maintenance, troubleshooting and cleaning of equipment used throughout the BacT/ALERT Manufacturing and Packaging processes.
• 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.

Primary Responsibilities:

• Production
  • Operate high speed manufacturing equipment, in some cases highly automated, using HMI/SCADA interfaces
  • Execute production activities per approved Manufacturing Directions while maintaining compliance with all job related SOPs
• 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
  • Provide assistance 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
  • Maintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirements
  • Operate cleaning equipment, utilize SOP and documentation to record data manually or through identified software applications.
• 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
  • 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
  • Perform computer applications
  • Perform other duties as assigned by Management

Education & Experience:

• High school diploma or GED required with 0 years of experience in a regulated production/operations environment
• Certification in a Bioworks Program or equivalent is preferred

Knowledge, Skills, & Abilities:

• 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.) preferred.
• Knowledge of FDA and/or GMP regulations preferred.
• Mechanical background preferred.
• Ability to rapidly learn new procedures and reduce them to practice.
• Must be able to learn, comprehend and demonstrate competency in operating new equipment within a 75-day period of working with a trainer.
• Perform all job functions and responsibilities in a safe and responsible manner.
• Ability to operate motorized pallet jacks.
• May be exposed to and require the handling of chemicals, antibiotics and/or hazardous materials.
• May be exposed to strong odors incurred during media production or other operations.
• Job Duties are performed wearing various types of PPE and cGMP which include but are not limited to a hairnet, beard cover, safety glasses, safety shoes, hearing protection, gloves, PAPR, face mask and lab coat.
• Ability to work overtime as required to support production operations