Senior/Principal Manufacturing Asset Engineer, HTO at F. Hoffmann-La Roche Ltd - Poland

Hillsboro, Oregon, United States -

Full Time

Start Date

Immediate

Expiry Date

07 Mar, 26

Salary

149500.0

Posted On

07 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Manufacturing Equipment, Data Analysis, Troubleshooting, Continuous Improvement, Capital Project Design, Qualification Strategies, Aseptic Processes, Team Collaboration, Root Cause Analysis, Good Manufacturing Practices, Health and Safety Compliance, Process Optimization, Maintenance Strategies, Asset Management, Engineering Solutions, Quality Management Systems

Industry

Biotechnology Research

Description

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. 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 8-11 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. The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $80,500 - $149,500 for the Senior level and $95,200 - $176,000 for the Principal Level . Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. 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 Link to Roche/Genentech Benefits #gnehtoengineers Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants. 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. The next step is yours. To apply today, click on the "Apply for this job" button. Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Responsibilities

The Senior/Principal Asset Engineer will support the design, operation, control, and optimization of manufacturing equipment. They will also provide technical support, ensure compliance with Good Manufacturing Practices, and contribute to maintenance and improvement strategies.