Maintenance Technician Job at Diasorin (Austin)

Job Description

The Maintenance Technician is primarily responsible for supporting the Operations teams by providing maintenance and repair support. The Maintenance Technician will perform operations to install, troubleshoot, repair and maintain production and facility equipment according to safety and quality standards. He/she is expected to take ownership of the repair and maintenance of a wide range of production and development equipment, verify and document work performed, and administer and maintain a spare parts and calibrations programs for production equipment.

Job Responsibility

Administer and execute a Preventative Maintenance Program and Calibrations Program for the equipment
Maintain a professional manufacturing environment for Medical Device Manufacturing
Administer, develop, and maintain a Spare Parts program
Read and understand electrical and pneumatic schematics, assembly drawings, data sheets, and process sheets to perform testing and troubleshooting of equipment
Troubleshoot Production Equipment problems, resolve, verify and document work performed
Maintain proper Equipment Documentation (Device Master Equipment Files) and maintain event records
Quantify processing times and identify areas for process improvements
Assist with hands on training of manufacturing employees on new tooling, equipment and process revisions
Assemble and modify tooling, fixtures, and equipment
Assists with Facilities maintenance on an as-needed basis
Assist Manufacturing Engineering in installing and validating equipment and processes in the production area following the established validation procedure
Assist Manufacturing Engineering in executing testing (FATs, SATs, IQ/OQ, Process and Product Qualifications and Validations)
Comply with policies, guidelines and regulatory requirements with the Luminex Quality System including FDA and ISO 13485 requirements
Interfaces/coordinates with departmental management to meet departmental maintenance objectives
Provides guidance and resolution to technical or operational problems
Assist Manufacturing Engineering with revisions and improvements to manufacturing methods and procedures, including writing change orders and deviations
Ability to work independently
Interacts with various internal and external groups to facilitate the resolution of manufacturing equipment mechanical problems
Ability to work flexible hours
Adherence to SOPs, including safety, hazardous waste disposal, and gowning requirements
Other related duties as assigned
Foresees issue before they surface
identify opportunities for equipment SPC.Mechanical and electrical aptitude

Requirements

H.S. Diploma Minimum High School Diploma or GED required
2+ Years of experience working in a manufacturing environment with hydraulics, pneumatics, mechanics, high and low voltage electrical and PLC troubleshooting and repair required
1+ Years Hands-on electro-mechanical assembly and troubleshooting experience preferred
1+ Years Experience with basic machine tools and fixturing desirable (mill, lathe, hand tools, etc.) preferred
1+ Years Experience working in a regulated environment (FDA, etc.) preferred
2+ Years in FDA regulated environment preferred
1+ Years Experience working independently in a fast-paced environment with rapidly changing priorities preferred
Ability to utilize illustrated parts breakdown manuals and operational manuals in the repair, modification and maintenance of equipment
Great attention to detail and commitment to excellence in review and work product
Ability to write detailed repair reports and records activities in the ERP system
Must have good mathematical skills, including basic algebra, to calculate electrical/electronic, fluid dynamics, and pressure equations as needed
Proficiency with the appropriate CAD software according to discipline
Proficiency with Microsoft Office applications
Thorough understanding of machine component design
Highly organized with proven time management and prioritization skills
Ability to work independently and with minimal supervision
Ability to excel in pressure situations to meet tight deadlines

Nice to have

Post-secondary education and/or a technical trade certificate preferred
1+ Years Hands-on electro-mechanical assembly and troubleshooting experience preferred
1+ Years Experience with basic machine tools and fixturing desirable (mill, lathe, hand tools, etc.) preferred
1+ Years Experience working in a regulated environment (FDA, etc.) preferred
2+ Years in FDA regulated environment preferred
1+ Years Experience working independently in a fast-paced environment with rapidly changing priorities preferred
Familiarity with cleanroom operations desired
Familiarity with fluid handling equipment and chemical/analytical equipment desired

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Maintenance Technician

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