Manufacturing Tech 1

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. This is a third shift position working Monday - Friday from 11 pm - 7:30 am.

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.

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.

Education & 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. Work experience accepted in lieu of a degree: No.

Key Skills (Knowledge, Skills & Abilities)

• Detail orientation to complete tasks without errors and produce high-quality work.
• Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently.
• Informing others by sharing clear, timely information to ensure alignment.
• Easily accessible and open to communication.
• Consistently uphold and reflects the core ethical principles and values that bioMérieux promotes.
• Actively and attentively listen to others, ensuring a clear understanding of their messages, needs, and concerns.

Working Conditions & Physical Requirements

Ability to remain in a 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. Must be able to push/pull objects up to 150lbs. 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.