Manufacturing Tech 1 (Service)

Title of Direct Supervisor: Manufacturing Production - Management 1

Position Summary

Local 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.

Responsibilities:

• 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.

Local 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

Experience

• 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.

Education and Training

• High School Diploma, GED or equivalent required.
• Certification in a Bioworks Program or equivalent is preferred.
• BioWorks, LEAN or other Continuous Improvement Certificate preferred.
• Will work experience be accepted in lieu of a degree? No

Key Skills, Knowledge and Abilities (KSAs)

• Intellectual Horsepower: Detail orientation to complete tasks without errors and produce high-quality work.
• Getting Organized: Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently
• Getting Work Done Through Others: Informing others by sharing clear, timely information to ensure alignment.
• Dealing with Complex Situations: N/A
• Relating Skills: Easily accessible and open to communication
• Acting with Honor and Being Open: Consistently uphold and reflects the core ethical principles and values that bioMérieux promotes
• Acting with Honor and Being Open: Actively and attentively listen to others, ensuring a clear understanding of their messages, needs, and concerns.

Working Conditions and Physical Requirements

• Ability to remain in stationary position, often standing, for prolonged periods. Yes
• Ability to ascend/descend stairs, ladders, ramps, and the like. Yes
• Ability to wear PPE correctly most of the day. Yes
• Ability to operate heavy machinery. Yes
• Ability to adjust or move objects up to 50 pounds in all directions. Yes
• Domestic travel required: 0%
• International travel required: 0%
• Total travel: 0%
• May be exposed to Static De-ionizing bars and require individuals with pacemakers to remain 21 inches away
• May be exposed to Chemical Hazards 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.
• 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.
• The job utilizes equipment and processes which include mechanical hazards, electricity hazards, and tripping / falling hazards.
• Must be able to push/pull objects up to 150lbs

Salary : $19 - $20