· Job facts
GENERAL ROLE SUMMARY / PURPOSE
As Equipment Support Engineer in Manufacturing, Science and Technology (MSAT) you will ensure equipment uptime by providing technical support to multiple Reagent Manufacturing laboratories in our Santa Clara GMP facility. Your areas of responsibilities will be implementation, optimization, maintenance, troubleshooting, adaptation of manual processes, and testing of automated processes in Sequencing Operations.
As our MSAT Equipment Support Engineer you will also be responsible for implementing Roche standards and methodologies, for documentation, and troubleshooting of a wide variety of equipment including automated liquid handlers, centrifuges, thermal cyclers, and other general laboratory equipment.
You will be working cooperatively in a busy laboratory environment, responding to change with flexibility and adapting quickly to evolving circumstances. Ongoing support for transferred processes will be necessary, requiring excellent interpersonal and communication skills.
You will be part of a highly skilled MSAT team who are dedicated to provide excellence in manufacturing across all the Global Sequencing Operations manufacturing sites from California to South Africa.
· Plan, execute, validate, calibrate and perform preventative maintenance for reagent manufacturing, dispensing, and testing equipment
· Work with Quality and Manufacturing to determine qualification, calibration and preventative maintenance requirements for equipment to comply with regulations
· Develop equipment installation and operational qualification test plans and protocols in accordance with design requirements, operational needs and applicable standards
· Develop and/or validate methods for equipment; perform engineering studies as needed
· Execute qualification and test protocols, compile test results, interpret data, and generate qualification reports
· Maintain records and Reagent Manufacturing environment to comply with cGMP, SOP and regulatory requirements
· Respond to instrument failures to minimize downtime
· Coordinate scheduled and unscheduled maintenance activities, including maintaining calibration/preventative maintenance/qualification database and serving as a point of contact for vendor service calls
· Perform service, preventative maintenance, modifications and installations on instruments with minimal supervision
· Facilitate introduction of new equipment into manufacturing laboratory
· Write and/or revise standard operating procedures
· Actively contribute in identifying quality gaps and support continuous improvement/operational excellence initiatives
· Purchase equipment and maintenance parts; resolve procurement issues with accounting, purchasing and legal departments as needed
· Partner with colleagues across the Roche network
Who we are
At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche 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.
Ideal candidate profile
Who you are
You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
Candidates for this role should hold the following qualifications, have the following experience, and be able to demonstrate the following abilities to be considered as a suitable applicant. Please note that except where specified as “preferred,” all points listed below are considered minimum requirements.
· BA/BS degree in biology, biochemistry, bioengineering or chemical engineering or equivalent experience
· 2-4 years of relevant experience working in a biochemistry or molecular biology laboratory setting
· Experience with next generation sequencing technologies, microarray technology, and data analysis tools highly desired.
· Experience deploying and supporting advanced liquid handling automation. Experience with Tecan Freedom EVO preferred
· Experience working in a cGMP or ISO regulated environment
· Experience deploying and supporting regulated medical device or IVD products
· Experience supporting clinical laboratory devices including liquid handling devices, imaging systems, and general lab equipment
· Strong written and verbal communication skills. Demonstrated capability to interface effectively with customers, management, and lab staff
· Strong partnering and collaboration skills; ability to work with all levels of staff and has exceptionally strong and highly effective working relationships across disciplines
· Ability to lead department and/or cross functional meetings or projects
· Ability to quickly adopt and apply new methods and technologies
· Proficiency in using basic word processing and spreadsheet applications
· Exceptional and evidenced organizational and analytical skills. Able to identify and resolve issues in timely manner
· Self-starter who thrives in a fast-paced and changing environment. Is able to deliver excellence under extreme pressure
· Ability to prioritize and drive to results with a high emphasis on quality
· Experience with 5S and Lean techniques is preferred