Principal Manufacturing Specialist, Aseptic Opertations

Overview

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.

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.

Responsibilities

• Set the strategic direction and framework of one or multiple programs for the Aseptic Operations Manufacturing organization in the areas of process development, process improvement, training, quality, and compliance. Manage deliverables within established programs and lead teams in their execution in line with site strategy.
• Develop and implement novel approaches to solving complex operational problems while maintaining required safety, quality (including regulatory compliance), and production. Provide support on projects related to manufacturing operations.
• Interpret customer functional and informational needs and translate them into data requirements, process models, and active systems. Build analytical tools using multiple data sources to automate data analytics and business performance indicators.
• 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.).
• Manage 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.).
• 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.
• Support the technical development and learning of Aseptic Operations Manufacturing organization and support group staff related to process improvements, Lean, Overall Equipment Effectiveness (OEE), and Root Cause Analysis (RCA).
• Support routine site regulatory inspections as a technical resource and Subject Matter Expert.

Qualifications

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 in the related policy.

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.

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.

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