Principal Manufacturing Specialist, Aseptic Opertations

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 manufacturing operations, which combine to produce millions of units of life-saving medicine every year to patients around the world.

This role is part of our Aseptic Operations Manufacturing organization and will collaborate with frontline, quality, and engineering to provide end-to-end oversight, management, and optimization of the manufacturing processes.

The Opportunity

As a Principal Manufacturing Technical Specialist, you will support the Process & Compliance team and serve the broader Aseptic Operations Manufacturing organization by driving business process improvements that significantly enhance operational performance and customer satisfaction, in the areas of quality, process capability, process reliability and robustness, operational efficiency, and standard work. You will contribute to a variety of initiatives and projects to address business challenges and unmet needs that apply across the Value Stream organization and support functions.

You will achieve this through cross-functional collaboration within 2 work-streams: Advance & Enable. The "Advance Team" sets the conditions for new process implementation, process validation, tech transfer & launch activities, and execution of process improvement initiatives; while the "Enable Team'' performs Batch Record Review, drives root cause analysis & CAPA determination, owns & improves Quality documents, defines key performance indicators and delivers business insights through data analytics & visualization.

• You will be responsible for setting the strategic direction and framework of the one or multiple programs for the Aseptic Operations Manufacturing organization in the areas of process development, process improvement, training, quality, and compliance. You will manage the deliverables within the established programs and lead teams in their execution in line with the site strategy.

• You will manage the development and implementation of novel approaches to solving complex operational problems while maintaining required levels of safety, quality (including regulatory compliance), and production. Provide support on projects related to manufacturing operations.

• You will interpret customer functional and informational needs and turn them into data requirements, process models, and active, functioning systems. You will build analytical tools, using multiple data sources, to automate data analytics and business performance indicators.

• You will perform critical, technical and operational review and approval of documentation related to the design, validation, operation and maintenance of HTO manufacturing processes, equipment and facilities (including engineering changes, document changes, validation documentation, etc.).

• You will be accountable for managing key operational support activities related to product transfers and new equipment/process start-up (manufacturing readiness and process design, documents, engineering runs, equipment set up, etc.).

• You will lead Root Cause Analysis and Structured Problem-Solving events and actively manage deviations, change records, and compliance actions related to operational activities, procedures and processes. Provide assessments on UPEs and PEs and Global Documents to identify gaps, ensure implementation plans are complete and will meet their intended purpose(s).

• You will support the technical development and learning of Aseptic Operations Manufacturing organization and support group staff as related to process improvements, Lean, Overall Equipment Effectiveness (OEE), Root Cause Analysis (RCA).

• You will support routine site regulatory inspections as a technical resource and Subject Matter Expert.

Who you are:

• You hold a Bachelor's degree in life sciences, physical sciences, engineering or an equivalent combination of education and work experience.

• You have 8+ years of progressive experience in the pharmaceutical industry.

• You are a strong problem-solver and have the demonstrated ability to troubleshoot and resolve process-related issues, ensuring efficient operations and regulatory compliance.

• You have a proven track record of working with large datasets (both structured and unstructured), presenting that data in meaningful ways and deriving actionable insights; presenting insights back to stakeholders.

• You possess a deep understanding of safety, quality systems, and quality assurance concepts including the application of current Good Manufacturing Practices (cGMPs) in aseptic processing and production.

• You have a working knowledge of aseptic processing principles, regulations, and industry guidelines relevant to biologics processing, including knowledge of quality assurance principles, quality systems, microbiology, and sterility assurance.

• You possess knowledge of scientific and engineering principles relevant to Aseptic Process & Equipment, which includes knowledge of aseptic manufacturing processing equipment and materials, such as isolators, filling, inspection & packaging machines, and sterilization systems, as well as the associated regulatory requirements.

• You are experienced in driving continuous improvement initiatives related to process, equipment, and quality systems.

The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $91,00 - $169,000. 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.

Link to Benefits

Relocation benefits are provided

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.

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