A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions that detect disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 5,000 team members across 12 sites or subsidiaries, including Salt Lake City based BioFire Diagnostics. We believe in the power of diagnostics and bioMérieux sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health across the globe. Come be a part of our mission to help save lives. Position Summary:
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.
Main Accountabilities: Production
- 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.
- This is a working mentor position in which approximately 50% of this position is performing the duties and/or training Process Technicians.
- The position will assist in providing general supervisory support to their Group Leads as needed.
- 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.
- 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
- 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
- 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.
Studies, Experience, Skills and Qualifications:
- 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 Group Lead (or higher) when needed
- Perform other duties as assigned by Management
- High School Diploma or GED Required, OR 2-3 years in a production environment with demonstrated maintenance and repair aptitude in lieu of degree
- Associates Degree in an applicable or Technical field or Vocational / Technical School & 1 year experience production environment and /or maintenance & repair
- Mechanical background required
- 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.
- Ability to rapidly learn new procedures and apply 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.
- Demonstrated experience of working independently
- Attention to detail and the ability to accurately interpret technical documentation
1. Performs all job functions and responsibilities in a safe and responsible manner.
2. Ability to regularly climb stairs to perform work.
3. Ability to routinely lift 25-50 lbs.
4. Ability to stand for extended periods of time on shifts that could range from 8-12 hours.
5. Ability to operate motorized pallet jacks.
6. May be exposed to and require the handling of chemicals, antibiotics and/or hazardous materials.
7. May be exposed to strong odors incurred during media production or other operations.
8. 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. Make-up and jewelry are prohibited in certain areas of Manufacturing.
9. Ability to maintain reliable and punctual attendance
10. Ability to work overtime as required to support a 24/7 production operation
Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. Our Group offers numerous possibilities: so come and join the 13,000 bioMérieux team members who already identify with these values!
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.
Job ID: 15890 Nearest Major Market:
Durham Nearest Secondary Market: