Position Summary:

The Process 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.

Responsibilities:

Production

• Formulation: 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 and Experience:

• High school diploma or GED required
• Minimum of 0-1 years in a regulated production/operations environment
• Certification in Bioworks Program preferred

Skills and Qualifications:

• 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.

Physical Requirements:

• 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 which include but are not limited to a hairnet, beard cover, safety glasses, safety shoes, hearing protection, gloves, PAPR, face mask and lab coat. 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