Sr. Supervisor, Maintenance

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The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. 

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