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Manufacturing Weekend 12hr DAY Shift
Ref No.: 23-106132
Location: Durham, North Carolina
Start Date: 10/20/2023

Position Summary:

The Manufacturing 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 Accountabilities:

· Production Manufacturing & Packaging: Operate high speed manufacturing equipment, in some cases highly automated, using HMI/SCADA interfaces

· Filling: 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, Experience, Skills and Qualifications:

· Experience: Minimum of 0-1 years in a regulated production/operations environment

· Skills Certification in Bioworks Program preferred.

· For Manufacturing and Packaging Demonstrated proficiency in the operation of high

· 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.

Additional Information:

· Performs all job functions and responsibilities in a safe and responsible manner.

· Ability to regularly climb stairs to perform work.

· Ability to routinely lift 20-40 lbs.

· 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