"Alerted.org

Position Summary & Responsibilities:

The normal working hours for this role are anticipated to be 2nd shift: Monday - Friday from 3:00pm - 11:30pm. The Sr 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.

+ Production

+ Operate and maintain highly automated bottle handling, filling, vision inspection, conveying, robotic palletizing, autoclaving, labeling and / or process batching equipment in a cGMP compliant manner, using HMI/SCADA interfaces

+ Setup high speed manufacturing equipment, within defined tolerances, to ensure product runs are started on time and within established guidelines

+ Check equipment during production runs for proper performance and assures the group leader the line is maintaining standard speeds

+ Troubleshoot simple to moderate equipment related issues

+ Execute production activities per approved Manufacturing Directions while maintaining compliance with all job-related SOPs

+ Quality

+ 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

+ Perform technical writing as it relates to Preventive Maintenance SOPs and Training SOPs and Technical Documentation

+ 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

+ Safety

+ Comply with all safety policies and procedures at all times

+ Appropriately use PPE (Personal Protection Equipment) as required to perfom routine and non-routines duties

+ Other Duties

+ Generate reports, charts and KPI's 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

+ Partner with maintenance staff to perform routine and preventative maintenance activities to include inspecting, lubricating, adjusting of manufacturing equipment in a timely basis to ensure reliability and minimize the incidence of unplanned downtime to production equipment.

+ Attention to detail and the ability to accurately interpret technical documentation are critical

+ Perform computer applications including learning and execution of SAP transactions

+ Leverage statistical process software to maintain optimal process centering

+ 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 requirements

+ Perform other duties as assigned by Management

+ Serves a back up to the Supervisor (or higher) when needed

+ Ensuring Productive Team Workflow to Meet Customer Demand: Coordinating the team’s workflow efficiently is fundamental to meeting customer expectations and maintaining business continuity. Any disruptions in workflow directly impact production targets, affecting customer satisfaction and, ultimately, the company’s financial health.

+ Resolving Technical and Material Flow Issues, Addressing Equipment Malfunctions: Prompt resolution of technical and material flow issues, along with immediate response to equipment malfunctions, is essential for uninterrupted production. Delays in addressing these issues can result in costly downtime, production losses, and increased maintenance expenses, significantly impacting the bottom line.

Experience, Skills and Education:

+ High School Diploma or GED and minimum of 5 years of relevant experience in a regulated production/operations environment

+ Equivalent military experience plus 4 years of relevant experience in a regulated production/operations environment also accepted

+ BioWorks, LEAN or other Continuous Improvement Certificate, or an Associate’s Degree with 4 years of relevant experience in a regulated production/operations environment also accepted

+ Certification in a Bioworks Program or equivalent is 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.

+ Ability to rapidly learn new procedures and reduce them to practice.

+ Must be able to learn, comprehend and demonstrate competency in operating new equipment within a 75-day period of working with a trainer.

+ Demonstrated experience of working independently

+ Attention to detail and the ability to accurately interpret technical documentation

+ Ability to operate motorized pallet jacks or forklift.

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