Senior/Principal Manufacturing Asset Engineer, HTO

Genentech-posted 7 days ago
Full-time • Senior
Hillsboro, OR
5,001-10,000 employees
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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 Senior/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.

  • 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.
  • You have a B.S or higher in Mechanical Engineering, Electrical, Chemical, Biochemical, or related discipline
  • You have 8-11 years experience in the pharmaceutical or biotechnology industry for a Senior Engineer and 12+ for a Principal Engineer level.
  • 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.
  • A discretionary annual bonus may be available based on individual and Company performance.
  • This position also qualifies for the benefits detailed at the link provided below.
  • This position is eligible for relocation benefits
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