A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.

Hillsboro Individualized Therapies is embarking on a transformative journey towards a digital future, and we are seeking an experienced and dynamic professional to lead the implementation of a Manufacturing Execution System at our state-of-the-art cell therapy manufacturing plant. This role is a valuable part of our Manufacturing Sciences and Technology (MSAT) team, which is committed to achieving our mission of delivering innovative cell and gene therapies to patients.

The Opportunity:

As a Principal Engineer specializing in Manufacturing Execution Systems (MES) and serving as the Process Owner, you will play a pivotal role in driving the optimization of our manufacturing processes. Your responsibilities will encompass designing, developing, implementing, enhancing, and maintaining the MES software application. The ultimate goal is to seamlessly integrate production operations with our business systems, leading to improved efficiency, reduced errors, and enhanced overall performance.

In this role, you will have the opportunity to shape the future of our manufacturing operations by leveraging your expertise in MES. By fostering collaboration with IT, IT/OT, manufacturing, and quality teams, you will ensure the successful deployment of the system and drive continuous improvement initiatives. Additionally, you will:

• Bring your technical knowledge and experience support testing, troubleshooting, and ongoing maintenance of the MES to ensure system reliability and the accuracy of data

• Remain up to date with emerging trends in MES technologies, ensuring that our MES system remains at the forefront of industry standards

• Ensure that documented processes and procedures are in place to meet quality and compliance standards, including GMP regulations

• Maintain compliance with industry-specific regulations, such as FDA guidelines and GMP requirements, Roche corporate policies and procedures, and local procedures to uphold product quality and safety through the MES system

• Utilize strong analytical and problem-solving skills in order to identify and address challenges that arise, further enhancing manufacturing operations

• Utilize excellent communication skills to enable you to effectively communicate project goals, progress, and outcomes to stakeholders at various levels of the organization

• Build and maintain robust relationships with key internal and external partners

Who you are:

• You hold a Bachelor's degree in software engineering, computer science, computer engineering, or a related field and deep knowledge and experience (10+ years) working with MES technologies such as Rockwell Automation Pharma Suite, Emerson Syncade, Siemens Camstar, Werum PAS-X, or Tulip

• You possess expertise with related technologies and standards, including ISA-95, OPC, and data historians

• You possess expertise in integrating MES systems with other Enterprise Resource Planning (ERP) systems and Supervisory Control and Data Acquisition (SCADA), to ensure seamless data flow and system interoperability

• You understand GMP regulatory requirements, such as FDA regulations for pharmaceutical manufacturing and experience with Computer System Validation

• You are a strong communicator with an interpersonal savvy to build relationships with stakeholders and articulate complex technical concepts to non-technical audiences

• You possess strong analytical and problem-solving skills to identify and resolve technical issues related to MES systems, configurations, and integrations

• You are adaptable, flexible and thrive in fast-paced, dynamic environments

• You have demonstrated experience mentoring and developing technical team members

• You possess exceptional leadership skills with the ability to inspire and lead cross-functional teams

Preferred:

• Advanced degree

• Expertise with programming languages such as C++, Java, Python, and SQL

• Scaled Agile Framework experience

• Understanding of cybersecurity concepts and best practices related to MES technologies

• Demonstrated success in operational excellence and process optimization

Relocation benefits are approved for this position.

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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.