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Line 1 Manufacturing Set Up Tech, 3rd 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 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. 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.  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. This is a working mentor position in which approximately 50% of this position is performing the duties of a Process Technician I/II/III and/or training others in the duties of a Process Technician I/II/III.  The position will assist in providing general supervisory support to their group lead as needed.


Main Accountabilities:

  • Execute production activities per approved Manufacturing Directions while maintaining compliance with all job related SOPs to support manufacturing, maintenance history records and training requirements. 
  • Ensure  all batch paperwork is completed in an accurate, thorough, and timely manner.
  • Generate reports, charts and KPI's and interpret the data to identify problems, and proceed with proper decision making.
  • Express ideas clearly (verbal and written) with the ability to work from verbal and/or written instructions, manuals, work orders and specifications.
  • 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.
  • Provide assistance as necessary with the review and revision of Manufacturing Directions and SOPs necessary for the manufacture and packaging of product.
  • Assist with manufacturing deviation analysis, CAPA actions and other process equipment related quality concerns.
  • Operate high speed manufacturing equipment, in some cases highly automated, using HMI/SCADA interfaces.
  • Follow appropriate departmental cleaning procedures to ensure adequate cleaning of the manufacturing areas.
  • Perform and document all processes and procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulations.
  • 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.
  • Maintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirements.
  • Assemble/disassemble processing equipment, clean manufacturing equipment parts, prepare bulk tubing kits and maintain daily use inventory. 
  • Ensure clean stored equipment dates are compliant with SOP clean standards. 
  • Self-audit rooms and processes.
  • Follow appropriate departmental cleaning procedures.
  • Perform necessary calculations and complex task sequences related to formulation, bulking and delivery of reagents in order to meet production requirements.
  • 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.
  • Measure or weigh precise amounts of chemical ingredients using both automated and manual systems for dispensing per associated Manufacturing Directions.
  • Operate and clean automated chemical dispensing equipment, mixers, pumps and related systems in the preparation of reagents used in BacT/ALERT Bottle filling.
  • Perform manual cleaning of tanks, valves, tubing, filter housings, work areas, etc.
  • Operate and maintain highly automated bottle handling, filling, vision inspection, conveying, robotic palletizing, autoclaving, labeling and process batching equipment in a cGMP compliant manner.
  • Setup and assist others in the setup of high speed manufacturing equipment, vision systems, and barcoding equipment  within defined tolerances, to ensure product runs are started on time and within established guidelines. Ability to troubleshoot issues with these various pieces of equipment.
  • Leverage statistical process software to maintain optimal process centering.  Check equipment during production runs for proper performance and assures the group leader the line is maintaining standard speeds.  Recommend changes in equipment that would benefit line performance.
  • Partner with maintenance staff to perform routine and Total Productive 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.
  • Demonstrate and work towards developing the following attributes:
    • Be open to change and new information; adapt behavior or work methods in response to new information, changing conditions, or unexpected obstacles.
    • Show understanding, courtesy, tact, concern, and respect to others; develop and maintain positive working relationships with others; may include effectively dealing with individuals who have different viewpoints; relates well to individuals from varied backgrounds.
    • Demonstrate cooperation within the organization and with teammates and cross-functional groups. 
    • Focus on internal developing oneself and staying open to coaching, mentoring and guidance by peers and the leadership team.
  • Perform other duties as assigned by Management.

 

Studies and Experience:

  • A High School Diploma or GED equivalent and a minimum of 5 years in a GMP regulated environment or
  • Associates Degree in an applicable or Technical field or Vocational / Technical School and a minimum of 3 years in a GMP environment
  • 4 years experience maintaining and repairing manufacturing equipment preferred

 

Skills and Qualifications:

  • Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.)Demonstrated proficiency in the operation of high speed, highly automated, production equipment is required.
  • Knowledge of FDA regulations required.
  • Mechanical background required.  
  • Background in Bulking and/or compounding in food, supplement, cosmetic, medical device, or pharmaceutical chemical formulation preferred. Familiarity with measurement scales, mixing, blending, chemical mills and other formulation manufacturing equipment preferred.   
  • Demonstrated experience of working independently .
  • Clean-room experience required.
  • Ability to work in a team environment with minimum supervision.
  • Proficient in the use of computers and Microsoft Office tools.
  • Ability to perform computer applications including learning and performing SAP transactions.
  • Attention to detail and the ability to accurately interpret technical documentation are critical.
  • Ability to troubleshoot moderate equipment related issues.
  • Ability to use standard mechanics tools including drill press, vise and bench grinder as necessary to service all manufacturing equipment. 
  • Ability to read and interpret Blue Prints and  Schematic Drawings.  Ability to perform Maintenance Focused Math and Measurements. 
  • Ability to perform technical writing as it relates to Preventive Maintenance SOPs and Training SOPs and Technical Documentation. 
  • 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.

 

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 routinely lift 20-40 lbs.
  • Ability to work overtime as required to support a 24/7 production operation.
  • Ability to operate motorized pallet jacks.
  • 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 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. 

 

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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