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The Sr. Supervisor, Maintenance position is located at our GenMark campus in Carlsbad, CA. Are you an experienced leader with a strong background in metrology, calibration, and preventative maintenance (PM)? We are seeking a proactive and detail-oriented Sr. Supervisor, Maintenance to join our team and ensure zero overdue PM tasks across all three shifts. In this critical role, you will drive process improvement initiatives. Your expertise with SAP and experience in maintenance will be essential as you lead a team of 6-8 direct reports.

The Opportunity

Organize and staff multiple shifts supporting operational needs. Continually maintaining a high level of qualified support.

Organize, schedule, maintaining and track the PM and Calibration activities. 

Ensure appropriate level of spare parts are available to support manufacturing and recommend and follow budget requirements.

Hire, train, mentor, supervise and develop maintenance personnel to ensure the appropriate resources and talent are in place. 

Tracks, analyzes, summarizes and reports key indicator data and metrics for areas of responsibility. 

Evaluate direct reports performance on an annual basis in a written performance review.

Monitor and track overtime to remain within budget guidelines.

Troubleshoot Mechanical, Electrical and Software related issues on GenMark’s ePlex Cartridge and Consumable manufacturing equipment

Make necessary repair and/or adjustments to manufacturing equipment with minimal engineering supervision

Recommend solutions to reoccurring issues and partner with Manufacturing Engineering to implement solutions

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

Good facilitation, communication, self-discipline, teamwork, and task organizational skill

Who you are

B.S. degree in Engineering or Science with ten (10) years of related experience in the medical device, pharmaceutical or similarly regulated industry. 

FDA, cGMPs, and/or ISO knowledge a plus

Experience implementing small to mid-size automation equipment required

Experience leading teams or projects required

Strong quality-orientation with attention to detail and a desire to deliver service excellence is essential

Asset Database Management system experience required

Experience with automated liquid reagent dispensing systems (Biodot, etc..) a plus

Experience with surface modification (plasma, Corona, etc..) and spray coating a plus

Experience with machine vision system (Cognex, Keyence, etc…) a plus

Skills – Technical

Strong problem-solving, judgment and decision-making skills

Must be experienced with the use of computer software programs such as Word, Excel

Experience with other Microsoft products a plus

Must be experienced with the use of Document Control systems. Preferably Master Control or other   

Direct hands-on experience in maintaining electro-mechanical equipment

Knowledge of CGMP, FDA 21 CFR-Part 820 required

Ability to analyze and troubleshoot both mechanical and electronic systems

Knowledge and experience with laboratory diagnostic instrument software and systems

Experience using documents and quality control procedures which include best practices

Knowledge of chemistry or biochemistry would be beneficial

Skills – General

Strong influencing and interpersonal skills and the ability to work well with others in a proactive, positive and constructive manner

Must be a hands-on, self-directed, organized and a conscientious individual

Must be able to think and work both tactically and strategically to provide operational needs to GenMark’s business

Ability to read, write and analyze complex documents

Ability to respond effectively to sensitive inquiries, customer inquiries or complaints as well as communicate effectively both orally and in writing with management, peers and individuals

Relocation benefits are not available for this posting

The expected salary range for this position based on the primary location of Carlsbad, CA is $78,800-$144,000.  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.