Supervisor, Maintenance (3rd Shift)

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GenMark is a leading company in the manufacturing, research, and development environments, dedicated to innovation and excellence. We are seeking a motivated and experienced individual to join our team as a Supervisor, Maintenance for our 3rd shift operations. In this role, you will supervise the maintenance department, overseeing the development and upkeep of manufacturing equipment, instruments, fixtures, and tooling essential for both manufacturing and research environments. You will ensure efficient organization and staffing across multiple shifts to support operational needs while maintaining a high level of qualified support.

As the Supervisor, Maintenance, you will be responsible for organizing, scheduling, and tracking preventative maintenance (PM) and calibration activities, ensuring an appropriate level of spare parts is available to support manufacturing needs, and recommending and adhering to budgetary requirements. You will hire, train, mentor, supervise, and develop maintenance personnel, conduct annual performance evaluations, monitor and manage overtime to stay within budget guidelines, and troubleshoot mechanical, electrical, and software issues on GenMark's manufacturing equipment. Additionally, you will make necessary repairs and adjustments to equipment and collaborate with Manufacturing Engineering to implement solutions for recurring issues.

Working hours: 9:30PM - 6:00AM

The Opportunity

• Support Manufacturing Engineering group with continuous process improvements projects and make recommendations to improve process and reduce scrap.

• Execute equipment validations (IQ/OQ/PQ) and document all activities following Good Documentation Practice

• Document Equipment and Engineering activities in accordance to established procedures, company policies, FDA, and other regulatory requirements

• Responsible for proper maintenance and care of commercial analytical instruments in a chemistry and biochemistry laboratory

• Responsible for maintaining manufacturing and R&D equipment and instruments to the manufacturers' specification

• Maintain test equipment, fixtures, and tooling needed to support manufacturing and R&D company needs

Who you are

• B.S. degree in Engineering or Science with 8-10 yrs experience in the medical device, pharmaceutical or similarly regulated industry. Plus 2-4 yrs of people management.

• FDA, cGMPs, and/or ISO knowledge a plus

• Essential qualities: strong quality-orientation, attention to detail, problem-solving, judgment, decision-making, and a desire to deliver service excellence.

• Hands-on experience in maintaining electro-mechanical equipment, analyzing, and troubleshooting both mechanical and electronic systems; experience with automated liquid reagent dispensing systems, surface modification techniques, and machine vision systems is beneficial.

• Knowledge and experience with laboratory diagnostic instrument software, quality control procedures, and chemistry or biochemistry is advantageous.

Required Experience:

• Implementing small to mid-size automation equipment

• Leading teams or projects

• Asset Database Management system

• Knowledge of CGMP, FDA 21 CFR-Part 820

Relocation benefits are not available for this posting

The expected salary range for this position based on the primary location of California is $73,600-$136,600. 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. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.