Manufacturing Tech 1 (Service) - 2nd Shift

Position Summary

The Manufacturing Technician position is responsible for the operation of high-speed equipment used in the production and packaging of BacT/ALERT bottles in a cGMP compliant manner.

Primary Duties

• Operate high speed manufacturing equipment, in some cases highly automated, using HMI/SCADA interfaces
• Execute production activities per approved Manufacturing Directions while maintaining compliance with all job-related SOPs
• 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
• Operate cleaning equipment, utilize SOP and documentation to record data manually or through identified software applications
• Perform self-audit of rooms and processes
• Train and certify teammates on production processes and procedures
• 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 all work in compliance with company quality procedures and standards
• Performs other duties as assigned

Qualifications

• Relevant experience in a regulated production/operations environment, OR equivalent military experience preferred
• Demonstrated proficiency in the operation of high speed, highly automated, production equipment preferred
• Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) preferred
• Knowledge of FDA and/or GMP regulations preferred
• Mechanical background preferred
• High School Diploma, GED or equivalent required
• Certification in a Bioworks Program or equivalent is preferred
• BioWorks, LEAN or other Continuous Improvement Certificate preferred

Working Conditions and Physical Requirements

• Ability to remain in stationary position, often standing, for prolonged periods
• Ability to ascend/descend stairs, ladders, ramps, and the like
• Ability to wear PPE correctly most of the day
• Ability to operate heavy machinery
• Ability to adjust or move objects up to 50 pounds in all directions
• May be exposed to chemical hazards and require the handling of chemicals, antibiotics and/or hazardous materials
• Ability to work extended and/or overtime hours as required to support production operations
• The job requires working 12-hour shifts which will include working on weekends and may include working overnight
• Must be able to push/pull objects up to 150lbs