Principal/Senior Principal Process Engineer, Aseptic Operations/Filling at Roche

Hillsboro, Oregon, United States -

Full Time

Start Date

Immediate

Expiry Date

12 Sep, 26

Salary

256750.0

Posted On

14 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Aseptic Processing, Technology Transfer, Process Validation, cGMP Regulations, Data Analysis, Statistical Tools, Root Cause Analysis, Project Management, Equipment Qualification, Commissioning, Risk Assessment, Gap Assessment, Regulatory Submissions, Cross-functional Collaboration, Mentoring, Troubleshooting

Industry

Biotechnology Research

Description

Genentech's Hillsboro Technical Operations (HTO), located in Hillsboro Oregon, is Drug Product manufacturing (Component Prep & Compounding, Liquid/Lyophilized Filling, Automated/Manual Inspection, Packaging/Finished Products and Distribution). This location is currently experiencing a period of growth, with a variety of opportunities to support optimization of our existing processes, as well as the delivery of new capabilities and technologies. We are a key aspect in a world-wide network of industry leading expertise and high performing pharmaceutical manufacturing facilities. Our work is critical in ensuring we reliably supply medicine to the millions of patients who currently depend on us, as well as reaching new patient populations. The Oppotunity: In this exciting position, you will focus on providing leadership and / or support of product tech transfers to the HTO site. As a Principal / Senior Principal Process Engineer, you will play a crucial role in ensuring the smooth and eﬃcient transfer of products, while maintaining the highest quality standards. You will work closely with cross-functional teams, including Manufacturing, Quality Assurance, and Engineering Science & Technology, ensuring compliance with regulatory requirements. You will support other engineers in the Process Engineering – Filling group, providing guidance and expertise in support of operations at the site. You will lead and participate in technology transfers and process validation activities, including project management, protocol development, execution, and report writing. You will support equipment qualiﬁcation and commissioning activities for new manufacturing equipment and processes. You will prepare and present rationale for tech transfer activities during periodic audits and regulatory inspections. You will author, review, and approve relevant sections of regulatory submissions. You will serve as a site representative on cross-functional and multi-site teams to support tech transfers and new technologies. You will lead and facilitate Gap Assessments, Risk Assessments, and other deliverables for tech transfers and NME launches. You will mentor and train junior level engineers. You will foster an environment that encourages continuous learning, maintaining expertise to stay abreast of technical and industry advancements and best practices related to aseptic processing. Who are you: You hold a BS/MS in Engineering, Pharmaceutical Sciences, or a related ﬁeld, and have the minimum years of relevant experience (Principal Engineer = minimum 8, Senior Principal Engineer = minimum 12). You have experience in the pharma/biotech industry. You have a strong knowledge of pharmaceutical/biologics processing principles, cGMP regulations, and regulatory requirements (e.g., FDA, EMA). You have in-depth knowledge of formulation, component preparation, and / or filling process development and characterization. You are proﬁcient in data analysis and statistical tools for process monitoring and optimization. You have excellent problem-solving and troubleshooting skills, with the ability to identify root causes and implement effective corrective actions. You have professional level communication and collaboration skills, with the ability to work effectively in a cross-functional team environment. You are detail-oriented, with a commitment to ensuring compliance and delivering high-quality results. The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $114,380 - $212,420 for the Principal Level and $138,000 - $256,750 for the Senior 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. Please note this role is eligible for relocation benefits. Link to Roche/Genentech Benefits 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

Lead and support product technology transfers to the Hillsboro Technical Operations site, ensuring compliance with quality and regulatory standards. Manage process validation, equipment qualification, and provide technical guidance to junior engineers within the aseptic filling group.