Principal Manufacturing Analytics Specialist, Process and Compliance

Hillsboro Technical Operations (HTO), located in Hillsboro Oregon, 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.

The Opportunity:

In this exciting role, you will focus on providing day-to-day operations support for our Inspection and Packaging Operations. You will play a crucial role in ensuring the smooth and efficient operation of our processes, while maintaining the highest quality standards. You will work closely with cross-functional teams, including Manufacturing, Quality Assurance, and Engineering & Science and Technology, to drive process improvements, troubleshoot issues, and ensure compliance with regulatory requirements. This role will drive 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 bring expertise in data monitoring and analytics to inform decision making in the manufacturing process and mentor others on this approach. You will participate in a variety of initiatives and projects to address business challenges and unmet needs that apply across the Value Stream organization and support functions. This is a hands-on role and the successful candidate will be comfortable working in an agile environment and is capable of interfacing with a wide variety of site and network stakeholders.

Key Responsibilities:

• You will own and actively manage complex deviations, planned events, and compliance actions related to operational activities, procedures and processes. You will provide assessments on deviations and PEs and Global Documents to identify gaps, ensure implementation plans are complete and will meet their intended purpose(s).

• You will lead, facilitate, and mentor Root Cause Analysis and Structured Problem-Solving events, to ensure deviations are thoroughly investigated and the appropriate remediation actions are defined and pursued, to ultimately reduce the number of repeat/recurring events.

• 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.). Where applicable perform critical technical and operational review and approval of the actual performance of the processes, equipment and facilities as it relates to the design, start-up, commissioning and qualification of new processes, equipment, procedures and facilities.

• You will implement production and large-scale manufacturing procedures to optimize processes and ensure compliance with regulatory requirements.

• 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 be accountable for technical development and learning of Finished Goods and support group staff as related to process improvements, tech transfers and process resolutions.

• You will review existing operational and process discrepancies in manufacturing and provide technical expertise to improve procedures.

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

• You will lead coordination and issue resolution across HTO Manufacturing Operations, support groups and/or projects (e.g. Operations Teams) as needed.

• You will provide technical support on projects related to manufacturing operations and frontline execution, including decision making authority when required or requested.

Who you are:

• You hold B.S degree (Preferably in Science or Engineering related fields)

• You have 4-7 years of previous experience in biotechnology or pharmaceutical manufacturing with understanding of cGMP principles..

• You have excellent written and verbal communication skills along with a strong desire to work in multifunctional teams.

• You have experience providing driving data-driven solutions within an operational environment, utilizing that skillset to drive continuous improvement and remediation for production issues.

• You are results-oriented, diligent and has a sense of urgency. Assertive, responsible for his/her own (self-directed) work, and is willing to commit to deadlines.

• You have proven ability to operate effectively in a global, matrixed, cross-functional environment with site, functional, and executive leadership.

• You are enthusiastic and energized about data and be driven to share that knowledge and excitement with others.

• You have proven experience of effective stakeholder management and strong influencing skills where there is not direct management control.

• You have strong analytical thinking, result-oriented team player and ability to prioritize and organize work effectively.

The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $76,100 - $141,300. 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. Relocation benefits are provided.

Link to Benefits

Relocation benefits are provided

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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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