Manufacturing Tech 2, Line 4 - 2nd shift

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.

Main Accountabilities:

• Production
  1. Manufacturing & Packaging: Operate high speed manufacturing equipment, in some cases highly automated, using HMI/SCADA interfaces
  2. Formulation: chemical weighing and reagent formulation
  3. Execute production activities per approved Manufacturing Directions while maintaining compliance with all job related SOPs
• Quality
  1. Ensure that all batch paperwork is completed in an accurate, thorough, and timely manner
  2. Perform and document all processes and procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulations
  3. Provide assistance with the review and revision of Manufacturing Directions and SOPs necessary for the manufacture and packaging of product.
  4. Assist with manufacturing deviation analysis, CAPA actions and other process equipment related quality concern
  5. Maintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirement
  6. Operate cleaning equipment, utilize SOP and documentation to record data manually or through identified software applications.
  7. Perform self-audit of rooms and processes.
• Safety
  1. Comply with all safety policies and procedures at all times
  2. Appropriately use PPE (Personal Protection Equipment) as required to perform routine and non-routine duties.
• Other Duties
  1. Generate reports, charts and KPI's and interpret the data to identify problems, and proceed with proper decision making
  2. Work with other departments and 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
  3. Attention to detail and the ability to accurately interpret technical documentation are critical
• 1. Perform computer applications including learning and execution of SAP transactions
  2. Communicate with Materials Management, Production Operations, and Quality Control on a daily basis to ensure the timely and efficient production of all of our customer requirement
  3. Perform other duties as assigned by Management

Studies, Experience, Skills and Qualifications:

• Experience
  • 1. Minimum of 2 years in a regulated production/operations environment
    2. Associates Degree in an applicable or Technical field or Vocational / Technical School preferred
    3. For Filling: a basic chemistry and lab application experience strongly desired
• Skills
  • 1. Certification in Bioworks Program preferred
    2. For Manufacturing and Packaging
       1. Demonstrated proficiency in the operation of high speed, highly automated, production equipment preferred.
    3. For Formulation
       1. Background in Bulking and/or compounding in food, supplement, cosmetic, medical device, or pharmaceutical chemical formulation is desired. 
       2. Familiarity with measurement scales, mixing, blending, chemical mills and other formulation manufacturing equipment strongly desired. 
    4. Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) preferred.
    5. Knowledge of FDA and/or GMP regulations preferred.
    6. Mechanical background preferred.
    7. Ability to rapidly learn new procedures and reduce them to practice. 
    8. Must be able to learn, comprehend and demonstrate competency in operating new equipment within a 75-day period of working with a trainer.
    1. Demonstrated experience of working independently
    10. Attention to detail and the ability to accurately interpret technical documentation

Additional Information:

• 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