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Sr. Manufacturing Technician - R&D Pilot Line

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

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.


Position Summary: 

The R&D Pilot Line Sr. Manufacturing Technician role is responsible for the operation of formulation, filling, autoclaving, and packaging equipment used in the production of medical devices with aseptic technique. This individual will assist in product development including setting up a pilot manufacturing line and scale-up to commercial line. Responsibilities will include setup, operation, part assembly, aseptic filling, and cleaning of equipment. Additionally, this individual will be responsible for AQL inspections, reworks, material reconciliation, and completing batch documentation. This role will manage Operational Job Aids, learning modules, SOP(s), continuous improvements initiatives, and associated small scale projects.


Primary Duties: 

  • Setup and Operate formulation, filling, autoclaving, packaging, and inspection equipment for pilot line production runs to support product development
  • Execute 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.
  • Check equipment for proper performance and ensure technical leads the line is maintaining standard speed
  • Troubleshoot simple to moderate equipment related issues
  • Maintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirements.  
  • Manage Small Scale Projects and Continuous Improvement Initiatives.
  • Express ideas clearly (verbal and written) with the ability to work from verbal and/or written instructions, manuals, work orders, and specifications. 
  • Provide assistance with the review and revision of Manufacturing Directions and SOPs necessary for the manufacture and packaging of product. 
  • Author and maintain Job Aids and Learning Module Certifications.
  • Support executing Commissioning and Qualification validation protocols associated with manufacturing/packaging equipment and procedures including revalidation as scheduled or required to maintain systems in a validated state.
  • 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.
  • Proficient in the use of computers and Microsoft Office tools.
  • 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. 
  • Perform other duties as assigned by Management.
  • Assess safety and environmental risks to ensure tasks adhere to HSE policies and HMS.

Supplemental Data:

  • Support Operation of Manufacturing, Formulation, Filling, and Packaging Equipment
    • Troubleshooting and resolution of equipment downtime events.
    • Provide support as a subject matter expert to maintain production equipment in a compliant and fit for intended use state.
    • Conduct Failure Investigations and implement solutions (corrective and preventive actions) that solve equipment mechanical problems, follow-up on corrective and preventive actions to determine their effectiveness and suitability, and prepare written reports on these activities in a timely fashion.
    • Analyze performance data to identify trends to predict potential failures and aid in solving product and process problems.
  • Demonstrating the behaviors of being a self-starter who is organized, detailed, conscientious, and ambitious.  Lead by example.
  • Models behaviors such as being a team player with a positive attitude, approaching projects/tasks with a sense of ownership, and developing and improving the skill level and behaviors of others. 
  • Effectively communicates within team and interfaces with other site departments, verbally and written. 
  • High level understanding of equipment, processes and products.


Training, Education, & Experience:

  • High School Diploma/GED with a minimum 5 years of technical experience focused on support of mechanical/production level equipment in a regulated industry required; ISO or FDA preferred. 
  • Associate’s degree with a minimum 3 years of technical experience focused on support of mechanical/production level equipment in a regulated industry preferred; ISO or FDA preferred. 
  • Minimum 3 years of experience working in a cGMP environment preferred.
  • Formulation: 1 year of basic chemistry and lab application experience strongly desired.
  • Experienced in the operation of high speed, highly automated, production equipment preferred.
  • Commissioning, Qualification, and Validation activities experience preferred.


Knowledge, Skills, & Abilities:

  • Knowledge of aseptic technique and good lab practices preferred. 
  • Familiarity with measurement scales, mixing, or automated to semi-automated filling equipment is 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.
  • Demonstrated ability to exercise diplomacy and problem solving skills when coordinating and working within all levels of the organization. 
  • Basic Computer Skills required; must be experienced and proficient in the use of Basic Microsoft Office tools (specifically Word & Excel).
  • Excellent documentation and communication skills (written & verbal). 
  • Strong attention to detail and GMP experience (including knowledge of change control, validation, and commissioning processes.)
  • Ability to work successfully autonomously, as an active contributor on a team/shift. 
  • Experience with equipment standard operation procedures (generation/revision) preferred.


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







BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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