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Manufacturing Technician
Ref No.: 24-183042
Location: Durham, North Carolina
Position Type:Contract
Start Date: 10/11/2024
Title: Manufacturing Technician
Location: Durham, NC 27712
Duration: 6+ Month
Shift: 7 pm-7:30 am Night (12hr B Shift), On a 2-2-3 rotation, OT may be required.

Job Description
  • 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.

Main Job Duties
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

Education & Experience
  • Minimum of High School Diploma or Equivlent
  • Minimum of 0-1 years in a regulated production/operations environment
  • Certification in Bioworks Program preferred
  • Demonstrated proficiency in the operation of high speed, highly automated, production equipment preferred.

Physical & Other Requirements
  • Ability to Lift 25-50lbs frequently and throughout shift
  • Ability to push and pull 50-100lbs frequently and throughout shift
  • 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