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The team, GenMark Diagnostics is a leading provider of multiplex molecular diagnostic solutions designed to enhance patient care, improve key quality metrics, and reduce the total cost-of-care. At GenMark, we’re changing the diagnostics landscape, combining out-of-the-box thinkers and game-changing technology to revolutionize patient care. Our work atmosphere is dynamic, fast-paced, and patient-focused. We encourage teamwork, while reinforcing the importance of individuality, and encouraging an entrepreneurial spirit

The Opportunity

The goal of the Maintenance Technician I in the GenMark team is to support the development and maintenance of manufacturing equipment, instruments, fixtures, and tooling used in manufacturing, research, and development environments.

The work schedule for this position is 2nd Shift: M-F 1:30 pm to 10:00 pm.

• Troubleshooting Mechanical, Electrical and Software issues on GenMark’s ePlex Cartridge and Consumable manufacturing equipment
• Performing assigned Preventive Maintenance on production equipment as well as maintain manufacturing and R&D equipment and instruments to the manufacturers’ specification, making necessary repairs and/or adjustments.
• Supporting Manufacturing Technical Operations group with continuous process improvement projects and making recommendations of solutions to recurring issues and partner with teams to implement solutions
• Assisting with equipment validations (IQ/OQ) and document all activities following Good Documentation Practice
• Documenting Equipment and Engineering activities in accordance with established procedures, company policies and FDA.
• Leading special projects as requested and perform additional duties as assigned

Who you are

• You hold a High School Diploma as is minimally required. You bring 2-5 years of experience in a regulated manufacturing environment as preferred.
• FDA, cGMPs, and/or ISO knowledge highly preferred, or equivalent experience
• Asset Database Management system experience required (SAP preferred)

Preferred behaviors, competencies, and qualities of the ideal applicant.

• Knowledge of CGMP, FDA 21 CFR-Part 820
• Ability to analyze and troubleshoot both mechanical and electronic systems. Direct hands-on experience in maintaining electro-mechanical equipment
• Knowledge and experience with laboratory diagnostic instrument software and systems
• Experience with automated liquid reagent dispensing systems (Biodot, etc..); with surface modification (plasma, Corona, etc..) and spray coating; with machine vision system (Cognex, Keyence, etc.) is a plus

Relocation benefits are not offered for this job posting.

The expected salary range for this position based on the primary location of California is 44,800 - 83,200. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses. GenMark’s ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.

GenMark is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.