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Position Summary:  The Manufacturing Set Up Technician position is responsible for the operation of high speed equipment used in the production and packaging of BacT/ALERT bottles and/or preparing and formulating the liquid reagents that fill the finished BacT/ALERT bottle in a cGMP compliant manner. 
<ul>
<li>The position may perform or assist in the setup, inspection, maintenance activities, troubleshooting and cleaning of equipment used throughout the BacT/ALERT Manufacturing and Packaging processes.</li>
<li>The maintenance activities include all aspects of production maintenance work including lubricating, preventive maintenance, and repair of manufacturing/packaging process equipment along with corresponding documentation.</li>
<li>The position will require periodic infrastructure cleaning (maintain clean work environment), utilizing tools, cleaning chemicals along with the corresponding documentation.</li>
<li>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.</li>
<li>This is a working mentor position in which approximately 50% of this position is performing the duties and/or training Process Technicians.</li>
<li>The position will assist in providing general supervisory support to their supervisors as needed</li>
</ul>
Primary Responsibilities: 
<ul>
<li>Production:</li>
<li>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</li>
<li>Setup high speed manufacturing equipment, vision systems and barcoding equipment within defined tolerances, to ensure product runs are started on time and within established guidelines</li>
<li>Check equipment during production runs for proper performance and assures the group leader the line is maintaining standard speeds</li>
<li>Troubleshoot moderate equipment related issues</li>
<li>Execute production activities per approved Manufacturing Directions while maintaining compliance with all job related SOPs to support manufacturing, maintenance history records and training requirements.</li>
<li>Maintenance:</li>
<li>Partner with maintenance staff to perform routine and Total Preventative Maintenance (TPM) 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.</li>
<li>Use standard mechanics tools including drill press, vise and bench grinder as necessary to service all manufacturing equipment.</li>
<li>Read and interpret Blue Prints and Schematic Drawings.</li>
<li>Perform Maintenance Focused Math and Measurements</li>
<li>Quality:</li>
<li>Ensure that all batch paperwork is completed in an accurate, thorough, and timely manner</li>
<li>Perform and document all processes and procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulations</li>
<li>Perform technical writing as it relates to Preventive Maintenance SOPs and Training SOPs and Technical Documentation</li>
<li>Assist with manufacturing deviation analysis, CAPA actions and other process equipment related quality concerns</li>
<li>Maintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirements</li>
<li>Operate equipment, utilize SOP and documentation to record data manually or through identified software applications.</li>
<li>Perform self-audit of rooms and processes</li>
<li>Train and certify teammates on production processes and procedures</li>
</ul>
Skills, Education, and Experience: 
<ul>
<li>High School Diploma or GED with 2-3 years of experience in a production environment with demonstrated maintenance &amp; repair aptitude OR Associate Degree in a related field OR Vocational / Technical School with 1 year experience production environment and/or maintenance &amp; repair</li>
<li>Electromechanical background preferred</li>
<li>Demonstrated proficiency in the operation of high speed, highly automated, production equipment preferred.</li>
<li>Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) and ISO preferred.</li>
<li>Knowledge of FDA and/or GMP regulations preferred.</li>
</ul>
#biojobs

Packaging Set Up Tech - Day Shift

Normal working hours: 7:00pm - 7:30am on a 2-2-3 schedule
Benefits at bioMerieux: Low-cost medical, dental, and vision benefits starting day one 11 paid holidays 160 hours of paid time off Annual bonus 9.5% 401k company contribution with no vesting period Tuition reimbursement up to $10,000 per calendar year Onsite cafeteria with daily food stipend
Position Summary: The Maintenance Technician 2 is responsible for direct support of all manufacturing process equipment at the bioMerieux, Inc. Durham Manufacturing Facility. This role involves performance of Preventive and Corrective maintenance by mechanical and/or electrical troubleshooting of specialized and highly automated process equipment. The candidate is also required to be an active contributor to failure root cause analysis, continuous improvement of departmental systems and infrastructure, and the Production Maintenance team. These responsibilities have the ultimate goal of supporting production to achieve output goals by maintaining the equipment to perform as designed thereby delivering a quality product.
Primary Responsibilities:
<ul>
<li>Performs, documents, and improves procedures and Preventative Maintenance Activities.</li>
<li>Adherence to FDA Regulations, GMP, ISO, HSE (OSHA), Department Procedures, and Manufacturing Directions.</li>
<li>Ensures the most recent information related to maintenance and reliability is communicated and/or documented for compliance, history, and reliability.</li>
<li>Strive towards continuous improvement of Preventative Maintenance procedures in pursuit of failure prevention and increased efficiency.</li>
<li>Maintains / Operates and troubleshoots highly automated mechanical and electrical systems with minimal supervision within a team environment.</li>
<li>Performs corrective maintenance activities as necessary and in compliance with site documentation and change control requirements.</li>
<li>Ensures that the automated mechanical and electrical systems meets and exceeds the Overall Equipment Effectiveness (OEE) goals determined by World Class Manufacturing standards to support business demands.</li>
<li>Ensures manufacturing line is operating at optimum level for a GMP environment in a Safe mode while meeting production goals.</li>
<li>Champion root cause analysis and continuous improvement to equipment/systems driving toward increasing reliability and minimizing the incidence of unplanned downtime to production equipment.</li>
</ul>
Knowledge, Skills, and Experience:
<ul>
<li>Associates degree in electronics technology or related trade with 2 years experience in electrical / mechanical maintenance or troubleshooting and repairing mechanical and electrical systems. -OR- 4 years of experience in electrical and mechanical maintenance or troubleshooting and repairing mechanical and electrical systems in lieu of degree.</li>
<li>Experience working in a cGMP/Regulated environment desired.</li>
<li>Ability to read ladder logic, troubleshoot and repair PLC’s, electrical systems, AC/DC drive systems, and mechanical systems desired. Proficiency in machining, welding, and fabricating a plus.</li>
<li>Experienced in the operation of high speed, highly automated, automated mechanical and electrical systems (preferably in a regulated environment within the last 6 years) desired.</li>
</ul>
#biojobs #BmxDUR

Manufacturing Maintenance Tech 2 - Night Shift

Benefits at bioMerieux: Low-cost medical, dental, and vision benefits starting day one 11 paid holidays 160 hours of paid time off Annual bonus 9.5% 401k company contribution with no vesting period Tuition reimbursement up to $10,000 per calendar year Onsite cafeteria with daily food stipend
Position Summary: Normal working hours: 7:00pm-7:30am working a 2-2-3 schedule
The Process Technician position is responsible for the operation of high speed equipment used in the production and packaging of BacT/ALERT bottles and/or preparing and formulating the liquid reagents that fill the finished BacT/ALERT bottle in a cGMP compliant manner.
<ul>
<li>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.</li>
<li>Additionally, this individual will be responsible for completing production batches and corresponding documentation for the associated tasks</li>
<li>AQL inspections, reworks and Material reconciliation that goes along with the batch.</li>
</ul>
Primary Responsibilities: 
<ul>
<li>Production:</li>
<li>Operate high speed manufacturing equipment, in some cases highly automated, using HMI/SCADA interfaces</li>
<li>Execute production activities per approved Manufacturing Directions while maintaining compliance with all job related SOPs</li>
<li>Quality:</li>
<li>Ensure that all batch paperwork is completed in an accurate, thorough, and timely manner</li>
<li>Perform and document all processes and procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulations</li>
<li>Provide assistance with the review and revision of Manufacturing Directions and SOPs necessary for the manufacture and packaging of product.</li>
<li>Assist with manufacturing deviation analysis, CAPA actions and other process equipment related quality concerns</li>
<li>Maintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirements</li>
<li>Operate cleaning equipment, utilize SOP and documentation to record data manually or through identified software applications.</li>
<li>Safety:</li>
<li>Comply with all safety policies and procedures at all times</li>
<li>Appropriately use PPE (Personal Protection Equipment) as required to perform routine and non-routine duties.</li>
<li>Other Duties:</li>
<li>Generate reports, charts and KPI's and interpret the data to identify problems, and proceed with proper decision making</li>
<li>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</li>
<li>Perform computer applications</li>
<li>Perform other duties as assigned by Management</li>
</ul>
Knowledge, Skills, &amp; Experience:
<ul>
<li>High School Diploma or GED Required</li>
<li>Certification in a Bioworks Program or equivalent is preferred</li>
<li>Demonstrated proficiency in the operation of high speed, highly automated, production equipment preferred.</li>
<li>Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) preferred.</li>
<li>Knowledge of FDA and/or GMP regulations preferred.</li>
<li>Mechanical background preferred.</li>
</ul>
#biojobs

3 General Maintenance Jobs in Durham, NC, USA