Principal Engineer, Manufacturing Execution System Process Owner

About the position

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. 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.

Responsibilities
? Design, develop, implement, enhance, and maintain the Manufacturing Execution System (MES) software application.
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? Drive the optimization of manufacturing processes through MES integration.
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? Collaborate with IT, IT/OT, manufacturing, and quality teams for successful system deployment.
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? Support testing, troubleshooting, and ongoing maintenance of the MES to ensure system reliability and data accuracy.
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? Stay updated with emerging trends in MES technologies to maintain industry standards.
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? Ensure compliance with quality and regulatory standards, including GMP and FDA guidelines.
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? Utilize analytical and problem-solving skills to identify and address challenges in manufacturing operations.
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? Communicate project goals, progress, and outcomes effectively to stakeholders at various levels.
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? Build and maintain relationships with key internal and external partners.

Requirements
? Bachelor's degree in software engineering, computer science, computer engineering, or a related field.
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? 10+ years of experience working with MES technologies such as Rockwell Automation Pharma Suite, Emerson Syncade, Siemens Camstar, Werum PAS-X, or Tulip.
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? Expertise with related technologies and standards, including ISA-95, OPC, and data historians.
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? Experience integrating MES systems with ERP systems and SCADA for seamless data flow.
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? Understanding of GMP regulatory requirements and experience with Computer System Validation.
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? Strong communication skills and interpersonal savvy to build relationships with stakeholders.
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? Strong analytical and problem-solving skills to resolve technical issues related to MES systems.
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? Adaptable and flexible, thriving in fast-paced, dynamic environments.
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? Experience mentoring and developing technical team members.
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? Exceptional leadership skills to inspire and lead cross-functional teams.

Nice-to-haves
? Advanced degree
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? Expertise with programming languages such as C++, Java, Python, and SQL
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? Scaled Agile Framework experience
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? Understanding of cybersecurity concepts and best practices related to MES technologies
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? Demonstrated success in operational excellence and process optimization.

Benefits
? Relocation benefits
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? Discretionary annual bonus based on individual and Company performance
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? Comprehensive health insurance
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? 401k retirement savings plan
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? Paid time off and holidays
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? Professional development opportunities

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