Production Operator

The Formulation 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.

Main Job Duties : 1. Production

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

b. Formulation : Chemical weighing and reagent formulation.

c. Execute production activities per approved Manufacturing Directions while maintaining compliance with all job-related SOPs.

2. Quality

a. Ensure that all batch paperwork is completed in an accurate, thorough, and timely manner.

b. Perform and document all processes and procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulations.

c. Provide assistance with the review and revision of Manufacturing Directions and SOPs necessary for the manufacture and packaging of the product.

d. Assist with manufacturing deviation analysis, CAPA actions, and other process equipment related quality concerns.

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

3. Safety

a. Comply with all safety policies and procedures at all times.

b. Appropriately use PPE (Personal Protection Equipment) as required to perform routine and non-routine duties.

4. Other Duties

a. Generate reports, charts, and KPIs and interpret the data to identify problems and proceed with proper decision-making.

b. 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.

c. Perform computer applications.

d. Perform other duties as assigned by Management.

Education & Experience :

Minimum of High School Diploma or Equivalent.

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 25-50 lbs frequently and throughout the shift.

Ability to push and pull 50-100 lbs frequently and throughout the 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, including but not limited to a hairnet, beard cover, safety glasses, safety shoes, hearing protection, gloves, PAPR, face mask, and lab coat.

Makeup 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.