Manufacturing Tech 2

BioMerieux•Durham, NC

1d•Onsite

About The Position

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.

Requirements

Minimum of 1 year of relevant experience in a regulated production/operations environment, OR equivalent military experience.
High School Diploma, GED or equivalent.

Nice To Haves

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.
Certification in a BioWorks Program or equivalent preferred.
BioWorks, LEAN or other Continuous Improvement Certificate preferred.

Responsibilities

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 KPIs and interpret the data to identify problems, and proceed with proper decision making.
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.
Perform computer applications including learning and execution of SAP transactions.
Communicate with Materials Management, Production Operations, and Quality Control on a daily basis to ensure the timely and efficient production of all customer requirements.
Assess when manufacturing or quality issues require escalation to senior staff or management to promptly address potential impacts on business continuity.
Execute tasks accurately and efficiently to meet customer expectations and maintain business continuity.
Perform all work in compliance with company quality procedures and standards.
Perform other duties as assigned.

Benefits

A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
Company-Provided Life and Accidental Death Insurance
Short and Long-Term Disability Insurance
Retirement Plan including a generous non-discretionary employer contribution and employer match.
Adoption Assistance
Wellness Programs
Employee Assistance Program
Commuter Benefits
Various voluntary benefit offerings
Discount programs
Parental leaves