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 a daily food stipend Normal working hours for this role are 7:00am - 7:30pm working a 2-2-3 schedule. 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 products.
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, and 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 with 0 years of experience
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 is preferred.
Mechanical background preferred.
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