Principal Manufacturing Asset Engineer, HTO
3 weeks ago
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. We believe every employee makes a difference. We are passionate about transforming patients' lives. We are courageous in both decision and action; we believe that good business means a better world.
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 Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche's commercial portfolio & pipeline products. The Operations organization at HTO is divided into 2 value streams, which combine to produce millions of units of life-saving medicine every year to patients around the world.
What you'll do:
As the the Principal Asset Engineer you will support the design, operation, control and optimization of manufacturing equipment at HTO. You will serve as the equipment owner and will be engaged in development, qualification, data analysis, troubleshooting, and continuous improvement activities. You will play a key role in day-to-day operations, as well as design and delivery of local and major capital projects, and interacts with a cross-functional team to deliver on business objectives.
You will:
Provide technical support and engineering solutions for process and equipment-related issues.
Understand the basis for the qualification of equipment and ensure that the equipment / systems remain in their qualified state and in alignment with Good Manufacturing Practices and all relevant Roche standards.
Collaborate with leadership to establish priorities, targets and milestones. Represent the department functionally, cross-functionally and cross-site for various activities and initiatives applying discretion to independently address issues or resolve problems.
Provide on-floor support to the Manufacturing teams regarding equipment. Ensure issues are identified and captured in the relevant quality management system, and that proper root cause analysis is performed with appropriate corrective and preventative actions assigned.
Contribute to the development of maintenance strategies, asset monitoring strategies, asset life-cycle management strategies, qualification strategies, spare part stocking strategies, etc.
Ensure changes, maintenance and other interventions do not impact the qualified state of the equipment and provide maintenance oversight for process equipment. Ensure any changes are documented appropriately through the change management system.
Use data-driven analysis of process and equipment to understand performance and capacity. Identify, recommend, and implement improvements to optimize system performance.
Ensure process operations comply with all health, safety, and environmental policies and procedures. Participate in Hazardous operations and process safety reviews and identify / mitigate hazards of manufacturing processes and equipment.
Who you are:
You have a B.S or higher in Mechanical Engineering, Electrical, Chemical, Biochemical, or related discipline
You have 8+ years experience in the pharmaceutical or biotechnology industry
You are a self-motivated team player with the ability to work, prioritize, and deliver results with minimal supervision.
You have a demonstrated success operating in teams (especially cross-functional teams)
You have strong organizational, computer, and analytical skills.
You have experience in capital project design, development, and execution.
You have an understanding of drug product and/or finished goods processes & equipment
You have experience in commissioning, qualification and validation activities associated with aseptic processes, technology transfers and new product commercialization.
This position is eligible for relocation benefits
Link to Roche/Genentech Benefits
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Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.
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