Senior/Principal Manufacturing Asset Engineer, HTO

Genentech-posted 3 months ago
$80,500 - $149,500/Yr
Full-time • Senior
Hillsboro, OR
5,001-10,000 employees
Professional, Scientific, and Technical Services
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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.

  • 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.
  • 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.
  • B.S or higher in Mechanical Engineering, Electrical, Chemical, Biochemical, or related discipline.
  • 8-11 years experience in the pharmaceutical or biotechnology industry for a Senior Engineer and 12+ for a Principal Engineer level.
  • Self-motivated team player with the ability to work, prioritize, and deliver results with minimal supervision.
  • Demonstrated success operating in teams (especially cross-functional teams).
  • Strong organizational, computer, and analytical skills.
  • Experience in capital project design, development, and execution.
  • Understanding of drug product and/or finished goods processes & equipment.
  • Experience in commissioning, qualification and validation activities associated with aseptic processes, technology transfers and new product commercialization.
  • Discretionary annual bonus based on individual and Company performance.
  • Relocation benefits.
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