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Manufacturing Tech 1 - 2nd shift

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

 

Position Summary:

The Process 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, preventive maintenance, troubleshooting and cleaning of equipment used throughout the BacT/ALERT Manufacturing and Packaging processes.
  • 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.

 

Responsibilities:

Production

  • Manufacturing & Packaging: Operate high speed manufacturing equipment, in some cases highly automated, using HMI/SCADA interfaces
  • Formulation: chemical weighing and reagent formulation
  • Execute production activities per approved Manufacturing Directions while maintaining compliance with all job related SOPs

 

Quality

  • 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
  • Provide assistance 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
  • Maintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirements

 

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.

 

Other Duties

  • Generate reports, charts and KPI's and interpret the data to identify problems, and proceed with proper decision making
  • 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
  • Perform computer applications
  • Perform other duties as assigned by Management

 

Studies and Experience:

  • High school diploma or GED
  • Minimum of 0-1 years in a regulated production/operations environment

 

Skills and Qualifications:

  • Certification in Bioworks Program preferred
  • For Manufacturing and Packaging
    • Demonstrated proficiency in the operation of high speed, highly automated, production equipment preferred.
  • For Formulation
    • Background in Bulking and/or compounding in food, supplement, cosmetic, medical device, or pharmaceutical chemical formulation is desired. 
    • Familiarity with measurement scales, mixing, blending, chemical mills and other formulation manufacturing equipment strongly desired. 
  • 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.

 

Physical Requirements:

  • Performs all job functions and responsibilities in a safe and responsible manner.
  • Ability to regularly climb stairs to perform work.
  • 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.
  • 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.
  • Ability to maintain reliable and punctual attendance
  • Ability to work overtime as required to support a 24/7 production operation

 

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