Principal Manufacturing Technical Specialist

The Opportunity

As a Principal Manufacturing Technical Specialist, you will support the Process & Compliance team and serve the broader Fill Finish 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 achieve this through multi-functional collaboration within 2 workstreams: 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 Fill Finish Value Stream in the areas of process development, process improvement, training, quality, and compliance. You will own the deliverables within the established programs and lead teams in their execution in line with the site strategy.

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

• You will support the technical development and learning of Fill Finish 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 a Bachelor's degree in life sciences, physical sciences, engineering or an equivalent combination of education and work experience and 8+ years relevant 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 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 solid understanding 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 able to work independently within broad guidelines and policies, with guidance in only the most complex situations.

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

Relocation benefits are available for this position.

The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $91,400 to $169,00. 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.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.