Filling

Roche•Hillsboro, OR

8d•$114,380 - $256,750•Onsite

About The Position

Genentech's Hillsboro Technical Operations (HTO) in Hillsboro, Oregon, is a Drug Product manufacturing facility that includes Component Prep & Compounding, Liquid/Lyophilized Filling, Automated/Manual Inspection, Packaging/Finished Products, and Distribution. The facility is currently experiencing growth and is seeking individuals to support process optimization and the implementation of new capabilities and technologies. This role is critical in ensuring the reliable supply of medicine to patients worldwide. In this position, you will focus on providing leadership and/or support for product tech transfers to the HTO site. 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 to support site operations. 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.

Requirements

BS/MS in Engineering, Pharmaceutical Sciences, or a related field.
Minimum 8 years of relevant experience for Principal Engineer, or minimum 12 years for Senior Principal Engineer.
Experience in the pharma/biotech industry.
Strong knowledge of pharmaceutical/biologics processing principles, cGMP regulations, and regulatory requirements (e.g., FDA, EMA).
In-depth knowledge of formulation, component preparation, and/or filling process development and characterization.
Proficient in data analysis and statistical tools for process monitoring and optimization.
Excellent problem-solving and troubleshooting skills, with the ability to identify root causes and implement effective corrective actions.
Professional level communication and collaboration skills, with the ability to work effectively in a cross-functional team environment.
Detail-oriented, with a commitment to ensuring compliance and delivering high-quality results.

Responsibilities

Lead and participate in technology transfers and process validation activities, including project management, protocol development, execution, and report writing.
Support equipment qualification and commissioning activities for new manufacturing equipment and processes.
Prepare and present rationale for tech transfer activities during periodic audits and regulatory inspections.
Author, review, and approve relevant sections of regulatory submissions.
Serve as a site representative on cross-functional and multi-site teams to support tech transfers and new technologies.
Lead and facilitate Gap Assessments, Risk Assessments, and other deliverables for tech transfers and NME launches.
Mentor and train junior level engineers.
Foster an environment that encourages continuous learning, maintaining expertise to stay abreast of technical and industry advancements and best practices related to aseptic processing.