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 rotation.

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

• Chemical weighing and reagent formulation

• 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.

• 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

• 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

• 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

• Perform other duties as assigned by Management

  Knowledge, Skills, & Experience:

• High School Diploma or GED Required with 2+ years in a regulated production/operations environment

• Associates Degree in an applicable or Technical field or Vocational / Technical School preferred

• Certification in a Bioworks Program or equivalent is preferred

• A basic chemistry and lab application experience strongly desired

• Background in bulking and/or compounding in food, supplement, cosmetic, medical device, or pharmaceutical chemical formulation is desired

• Familiarity with measurement scales, mixing, blending, chemical mills, and other formulation manufacturing equipment strongly desired

• Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) preferred.

• Knowledge of FDA and/or GMP regulations preferred.

• Mechanical background preferred.

  Physical Requirements:

• Ability to remain in stationary position, often standing, for prolonged periods.

• Ability to ascend/descend stairs, ladders, ramps, and the like.

• Ability to wear PPE correctly most of the day.

• Ability to operate heavy machinery.

• Ability to adjust or move objects up to 50 pounds in all directions.

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