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:
Normal working hours: 7:00pm - 7:30am working a 2-2-3
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 task
• 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

Knowledge, Skills, & Experience:

• High School Diploma or GED Required
• Certification in a Bioworks Program or equivalent is 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.) preferred.
• Knowledge of FDA and/or GMP regulations preferred.
• Mechanical background preferred.