The PositionAs a Sr.
Maintenance Technician, you will troubleshoot mechanical, electrical and software related issues on GenMark’s ePlex Cartridge and Consumable manufacturing equipment.
You will also perform assigned Preventative Maintenance on product equipment and support the development and maintenance of manufacturing equipment, instruments, fixtures, and tooling used in manufacturing, research, and development environments.The Sr.
Maintenance Technician will document equipment and engineering activities in accordance to establish procedures, company policies, and FDA regulations.
As well as possess direct hands-on experience in maintaining electro-mechanical equipment and the ability to analyze and troubleshoot both mechanical and electronic systems.
You will also assist with improving the spare parts program and tooling needed to support manufacturing and R&D company needs.
In addition to assisting with special projects as requested and performing additional duties as assigned.
Individuals that are self-disciplined and collaborative with effective facilitation, communication, and task organizational skills are highly desired.Key ResponsibilitiesMake necessary repair and/or adjustments to manufacturing equipment with minimal engineering supervisionTrain all junior technicians in the theory and operation of all equipment.Recommend solutions to reoccurring issues and partner with Manufacturing Engineering to implement solutionsSupport 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 Responsible for maintaining manufacturing and R&D equipment and instruments to the manufacturers’ specificationWho you areHigh School Diploma or equivalent with at least 7 years of technical experience in a regulated manufacturing environment requiredAssociate Degree in an engineering or scientific field with 5 years of experience in a regulated manufacturing environment or military experience in a technical role in lieu of degree and required experience.FDA, cGMPs, and/or ISO knowledge is preferredStrong quality-orientation with attention to detail and a desire to deliver service excellence is essentialAsset Database Management system experience requiredKnowledge of CGMP, FDA 21 CFR-Part 820 requiredStrong problem-solving, judgment and decision-making skillsMust be experienced with the use of computer software programs such as Word, ExcelKnowledge and experience with laboratory diagnostic instrument software and systemsExperience using documents and quality control procedures which include best practicesPreferred QualificationsFDA, cGMPs, and/or ISO knowledgeExperience with automated liquid reagent dispensing systems (Biodot, etc.)Experience with surface modification (plasma, Corona, etc.) and spray coatingExperience with machine vision system (Cognex, Keyence, etc.)Relocation assistance is NOT available for this roleWho we areGenMark 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.