To support the development and maintenance of manufacturing equipment, instruments, fixtures, and tooling used in manufacturing, research, and development environments.
Your key responsibilities
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
Perform assigned Preventive Maintenance on production equipment.
Train all junior technicians in the theory and operation of all equipment.
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) and document all activities following Good Documentation Practice
Document Equipment and Engineering activities in accordance to established procedures, company policies and FDA.
Responsible for maintaining manufacturing and R&D equipment and instruments to the manufacturers’ specification
Assist with improving spare parts program and tooling needed to support manufacturing and R&D company needs
Good facilitation, communication, self-discipline, teamwork, and task organizational skills
Assist with special projects as requested and perform additional duties as assigned
Who you are
Associate degree in an engineering or scientific field, FDA, cGMPs, and/or ISO knowledge highly desired or equivalent experience
Five to ten (5-10) years of experience in a regulated manufacturing environment desired
Strong quality-orientation with attention to detail and a desire to deliver service excellence is essential
Asset Database Management system experience required
Knowledge of CGMP, FDA 21 CFR-Part 820 required
Strong problem-solving, judgment and decision-making skills
Must be experienced with the use of computer software programs such as Word, Excel
Direct hands-on experience in maintaining electro-mechanical equipment
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
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
Relocation is NOT available for this role.Who we are
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.