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Manufacturing Team Lead - 2nd Shift

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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 which determine the source of disease and contamination to improve patient health and ensure consumer safety.

In North America we have more than 5,000 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.


Come and join a family-owned global company with a long-term vision, and a human-centered culture.

Position Summary:

The Team Lead position is responsible for front-line leadership of a team engaged in the operation of high speed manufacturing/packaging equipment and/or process-driven Reagent formulation. 

 

The Team Lead position includes

  • all aspects of production/packaging and maintenance work including inspection, maintenance, cleaning, troubleshooting and repair of manufacturing/process equipment
  • assist in the development of employees
  • drive accountability for team performance metrics and projects
  • effectively leading quality initiatives critical to the department’s ability to improve manufacturing processes
  • improve departmental productivity, efficiency, and product quality
  • reduce manufacturing costs/scrap

 

Responsibilities:

Leadership

  • Serve as back up to the Group Lead (or higher) when needed
  • Develop manufacturing team
    • Inspire and motivate manufacturing team to achieve top performance as a team
    • Inspire and promote self-growth and internal development within the team
  • Assist in management of daily activities i.e; scheduling production activities & Daily shift tie-in meetings
    • Generate reports, charts and KPI's and interpret the data to identify problems, and proceed with proper decision making
    • Conduct staff meetings daily or as needed, keeping records/documentation of what is discussed

 

Production

  • Manufacturing & Packaging: Operate and maintain highly automated bottle handling, filling, vision inspection, conveying, robotic palletizing, autoclaving, and / or labeling equipment in a cGMP compliant manner, using HMI/SCADA interfaces
    • Setup high speed manufacturing equipment, within defined tolerances, to ensure product runs are started on time and within established guidelines
  • Provide feedback on design and operation of equipment to optimize manufacturing
  • Check equipment during production runs for proper performance and assures the equipment is maintaining standard speeds and process times
  • Troubleshoot simple to moderate equipment related issues

 

Quality

  • Right First Time (RFT): minimal deviations and error free performance
    • Ensure that all batch paperwork is completed in an accurate, thorough, and timely manner
    • Execute production activities per approved Manufacturing Directions while maintaining compliance with all job related SOPs
  • Assist with manufacturing deviation analysis, CAPA actions and other process equipment related quality concerns
  • Perform self-audit of rooms and processes

 

Documentation / Training

  • Utilize SOP and documentation to record data manually or through identified software applications
  • Assist in the development, revision of manufacturing procedures and training programs for manufacturing employees.
  • Ensure overall team training is maintained current for processes and procedures relevant to all area activities
  • Coordinate cross-training among roles to create staffing flexibility and increased depth.

 

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.
  • Monitor workers on site during production activities to ensure adherences to ethics and safety procedures

 

Continuous Improvement

  • Lead and promote continuous improvement through team and individual initiatives
    • Identify areas of deficiency and implement practices to improve employee safety and to reduce the cost incurred through excessive scrap, poor workflow/process design and others
    • Serve as a project team member to reduce scrap, increase product quality, decrease operational costs, and improve departmental efficiency/productivity
    • Serve as change agent by driving the required cultural transformation and the adoption of successful process improvement practices. Diagnoses barriers to project success and facilitates resolution
  • 5S:  Maintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirements

 

Other Duties

  • Assist in creation and implementation of training/development plans for new equipment and assigned teammates
  • Ensure overall team training is maintained current for processes and procedures relevant to all manufacturing/packaging activities and coordinate cross-training among roles to create staffing flexibility and increased depth
  • Contribute to team goal development, status tracking and communication by providing feedback to the direct manager for the PMP (Performance Management Program) process
  • 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
  • Partner with maintenance staff to perform routine and  preventative maintenance 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
  • 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

 

Studies and Experience:

  • High school diploma or GED
  • Minimum of 5 years in a regulated production/operations environment required
  • Associates Degree in an applicable or Technical field or Vocational / Technical School and 4 years  experience in a regulated industry preferred

 

Skills and Qualifications:

  • 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 preferred.
  • Mechanical background preferred.
  • Ability to rapidly learn new procedures and reduce 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

 

Physical Requirements:

  • Performs all job functions and responsibilities in a safe and responsible manner.
  • Ability to regularly climb stairs to perform work.
  • Ability to stand for extended periods of time on shifts that could range from 8-12 hours.
  • Ability to operate motorized pallet jacks.
  • May be exposed to and require the handling of chemicals, antibiotics and/or hazardous materials.
  • May be exposed to strong odors incurred during media production or other 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.
  • Ability to maintain reliable and punctual attendance
  • Ability to work overtime as required to support a 24/7 production operation

 

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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