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Manufacturing Technician - R&D Pilot Line

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Location: Durham, United States
Position Type: Unfixed Term
Job Function: Manufacturing

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 Technician 1 is responsible for the operation of equipment used in the production of medical devices with aseptic technique preferred. This individual will assist in product development including setting up a pilot manufacturing line. Responsibilities will include setup, part assembly, aseptic filling, and cleaning of equipment. Additionally, this individual will be responsible for completing batch documentation.


Main Accountabilities:

  1. Participate in new product development and assist with pilot line production runs
  2. Execute pilot production activities per approved Manufacturing Directions while maintaining compliance with all job related SOPs. Ensure that all batch paperwork is completed in an accurate, thorough, and in a timely manner.
  3. Express ideas clearly (verbal and written) with the ability to work from verbal and/or written instructions, manuals, work orders, and specifications.
  4. 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.
  5. Provide assistance with the review and revision of Manufacturing Directions and SOPs necessary for the manufacture and packaging of product.
  6. Perform and document all processes and procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulations.
  7. Comply with all safety policies and procedures at all times.
  8. Appropriately use PPE (Personal Protection Equipment) as required to perform routine and non-routine duties.
  9. Proficient in the use of computers and Microsoft Office tools.
  10. Maintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirements. 
  11. Demonstrate and work towards being open to change and new information; adapt behavior or work methods in response to new information, changing conditions, or unexpected obstacles.
  12. Perform other duties as assigned by Management.
  13. Assess safety and environmental risks to ensure tasks adhere to HSE policies and HMS

 

Studies and Experience:

  • A High School Diploma or GED equivalent and a minimum of 0-1 years in a regulated production/operations environment required, preferably in the pharmaceutical/biotech industry.
  • Associates Degree in an applicable or Technical field or Vocational / Technical School preferred.
  • A minimum of 0-1 years in a regulated production/operations environment, preferably in the pharmaceutical/biotech industry required.

 

Skills and Qualifications:

  • Knowledge of aseptic technique and good lab practices preferred.
  • Knowledge of FDA and/or GMP regulations preferred.
  • Ability to rapidly learn new procedures.  
  • Must be able to learn, comprehend and demonstrate competency in operating new equipment within a 75 day period of working with a trainer.
  • Ability to work in a team environment with minimum supervision.


Additional Information:

  • Ability to stand for extended periods of time on shifts that could range from 8-12 hours.
  • Ability to routinely lift 20-40 lbs.
  • Ability to maintain reliable and punctual attendance.
  • May be exposed to and require the handling of chemicals, antibiotics and/or hazardous materials.
  • May be exposed to strong odors incurred during operations.
  • Lab work is performed wearing various types of PPE which include but is not limited to a hairnet, beard cover, safety glasses, safety shoes, hearing protection, gloves, PAPRs, face mask and lab coats. Make-up and jewelry are prohibited in certain areas of Manufacturing.

 

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.

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