California, United States of America
This position is located at Genentech's Hillsboro Technical Operations facility (HTO) in Hillsboro, Oregon. This position is accountable for engineering project execution for HTO Inspection Manufacturing processes while maintaining compliance with current Good Manufacturing Practices (cGMP) and Genentech quality and safety policies and standards. This position will support the testing and qualification of the automated visual inspection process in a biologic manufacturing environment as an integral part of product launches from the facility.
The individual in this role will support project execution of a new filling line for a new drug product at HTO. Tasks include but are not limited to; coordinating and performing defect set creation and detection characterization tests, organizing and maintaining test material for use in studies, drafting engineering studies and summary reports, collecting and analyzing data, and executing qualification tests.
The individual in this role will work under the direction of the Engineering Manager and will be assigned to support project leads in project execution. The individual will primarily be working hands-on with equipment in the manufacturing environment, executing tests, and collecting data. While primarily a day-shift role, based on the equipment availability, some work time will include swing shift and weekends to achieve scheduled timelines to complete testing. Expect a dynamic environment where coordination with other functional groups is necessary to complete assigned tasks.
Mechanical Engineering, Electrical Engineering or other engineering (Bio Engineering, Chemical Engineering) degree
1 to 2 years of technical writing experience
Good communication skills
Good attention to detail, quick leaner, results oriented
Ability to work with limited direction to organize and accomplish assigned tasks
Experience with MS Office Suite
Flexible work schedule - up to 10% of the work in a given month may be on swing or weekend shifts
Additional desired skills:
Knowledge of basic statistical analysis methods; T-test, F-test, Fischer Test, attribute control charts
Experience managing projects focused on process improvement
Experience with Minitab software
Experience with engineering studies and/or Design of Experiments
Knowledge with change control processes in a cGMP environment
Experience working in a cleanroom environment
Experience with operation or maintenance of high speed mechanical equipment such as packaging lines, automated inspection machines, or the equivalent
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
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Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.
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