Title: Bulk Formulation Technician
Location: Durham, NC 27712
Duration: 6+ Month with high possibility of extension
7:00p-7:30a (Shift B, 2-2-3 rotation)

Job Description
12-hr NIGHT/rotating B-shift
7:00p-7:30a (Shift B, 2-2-3 rotation)
Position Summary

The Formulation Technician position is responsible for the operation of high speed equipment used in the production of BacT/ALERT bottles and/or preparation, staging, weighing of raw materials used for the formulation of 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.

· The position consists of the staging and preparation of raw materials used for Media Formulation

· Additionally, this individual will be responsible for completing production batches and corresponding documentation for the associated tasks

· Shift hours: 7:00a-7:30pm / Day Shift/A Team 12 hr shift 2-2-3 Schedule

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

· Experience in weighing/Staging of raw materials used in large scale production preferred

· Skills

· Certification in Bioworks Program 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.

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 50-75 lbs.

· Heavy lifting Involved

· 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