Manufacturing technician / Machine Operator

Job Title : Manufacturing Technician - Weekend 12hr - DAY Shift

Contract : 18 months

Schedule : Friday- Sunday 7 : 00am-7 : 30pm

Location : Durham, NC

Job Description : 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 :

Additional Information :