Genentech Senior/Principal Engineer, Process Engineering (HIT) in Hillsboro, Oregon
Senior/Principal Engineer, Process Engineering (HIT)
Oregon, United States of America
Job ID: 202009-123117
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Please note there are multiple positions available
Main Purpose of the Position:
This position is part of the Manufacturing Science and Technology (MSAT) function at Genentech’s Hillsboro Individualized Therapies Operation (HIT). HIT is a new manufacturing facility focused on delivering novel therapies that are uniquely manufactured for each patient.
In this role, you will design, install, test, and validate state-of-the-art manufacturing equipment intended to produce medicine on a per-patient basis. Additionally, you will write product impact assessments, sampling, plans, technical reports, and provide technical assessments, rationales and approval for engineering and process changes and documentation pertaining to process development, qualification, and validation to meet regulatory requirements.
Provide technical support and training to Operations and Maintenance
Build reliability into Operations equipment and processes
Establish equipment failure and risk analysis processes to increase reliability
Provide frontline troubleshooting and issue resolution support for operations.
Support product & component introductions
Identify and implement batch & yield improvements
Identify and implement process & safety improvements
Support Investigations and atypical events, as well as resulting corrective or preventive action implementation
Root cause analysis facilitation/participation
Development and execution of integrated, startup, and qualification (IQ/OQ/PQ) activities
Training program development; Participate in FAT efforts at vendor sites
Identify, evaluate, and implement new process technologies in alignment with business objectives or regulatory requirements
Qualifications / Requirements:
B.S. degree engineering or related field
Possess a minimum of 8 years of experience in the Pharmaceutical Field
Experience with cell therapy manufacturing is preferred
Knowledge of filling and related equipment and processes is preferred
Key to this position is the demonstrated ability to provide technical leadership and teamwork in a cGMP environment across functional and organizational boundaries
Excellent communication skills are a must
Ability to assess and develop timely, effective solutions for manufacturing equipment and processes is key
Six Sigma Green or Black Belts is a plus
Who We Are
Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.
Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.
The next step is yours. To apply today, click on the "Apply for this job" button.
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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