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
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
Note:
12-hr Day/rotating shift
7:00a-7:30p (2-2-3 rotation) Overtime likely available
VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status