Manufacturing IT OT Systems Application Engineer

Genentech - Hillsboro, OR

Full-time

Hillsboro, OR

Chemical Manufacturing

About the position

As a Manufacturing IT OT Systems Application Engineer, you will play a crucial role in the Hillsboro IT OT team, reporting directly to the Manufacturing Systems Lead. This position is integral to the Pharma Global Technical Operations (PT) at Roche, which is dedicated to producing lifesaving medicines across 11 locations worldwide. The IT and Automation Technology (OT) teams are pivotal in ensuring the efficient production and delivery of these medicines, especially as the organization undergoes a significant transformation towards digitalization. This transformation aims to enhance competitiveness in the market by leveraging new technologies and optimizing existing processes. In this role, you will take on System Ownership and local Product Ownership responsibilities for Manufacturing IT/OT Applications within a 24x7 Good Manufacturing Practice (GMP) environment. Your primary focus will be on supporting Product Transfers and the Make/Assess/Release processes. You will collaborate with the Site Team and the broader Global IT OT organization to contribute to Manufacturing Operations Management initiatives, driving optimization and standardization across the global IT OT landscape. Your responsibilities will include overseeing the procurement, development, integration, modification, operation, maintenance, validation, and retirement of site-specific OT systems, such as LyoPlus, Ellab, WAGIT, FIT, and SRS. You will troubleshoot system issues, participate in after-hours on-call support, and manage risks associated with system integration and upgrades. Additionally, you will conduct periodic system reviews, user account management, and ensure compliance with GMP standards while working closely with Business Process Owners. Your role will also involve creating and maintaining system lifecycle documents and procedures, representing application dependencies, and practicing disaster recovery and backup/restore processes. As a member of Build and Run Squads, you will provide leadership and technical expertise through an Agile delivery model.

Responsibilities

• Take over the responsibility as a System Owner/Local Product Owner for Manufacturing IT Applications in a 24x7 Good Manufacturing Practice (GMP) environment.
• Responsible for the overall procurement, development, integration, modification, operation, maintenance, validation, and retirement of site specific OT systems.
• Troubleshoot immediate system issues, and inquiries as they arrive during normal business hours.
• Participate in an after hours on-call support rotation.
• Determine and mitigate any risks associated with integration and/or upgrade of administered systems.
• Host/guide/monitor vendors on site for activities related to administrated systems.
• Perform system periodic reviews, including data collection from the deviations database and drafting reports.
• Responsibility for the Periodic System Audit Trail Review.
• User account auditing, provisioning, resets and activation for all IT and OT systems.
• Work with Business Process Owners for the upgrade/patching and changes to the system to ensure GMP compliance.
• Review ServiceNow tickets and either address them or route them to the SME.
• Creating and maintaining system lifecycle documents and procedures using document management systems.
• Represent and mitigate application dependencies as related global systems evolve their business processes and technologies.
• Develop, maintain, and practice Disaster Recovery and backup/restore processes.
• Provide leadership, technical expertise and local implementation experience as a member of Build and Run Squads.

Requirements

• Bachelor's degree in Engineering (Computer/Automation Engineering preferred).
• Minimum 5 years of experience in system and/or network administration.
• Prior experience in working closely with IT OT providers/vendors.
• Biopharmaceutical or similar Manufacturing domain knowledge.
• Experienced with troubleshooting OT systems hardware and software.
• System administration and/or system design experience in a cGMP environment.
• Proficiency in Windows Server and Network Administration.
• Experience with industrial data and control interfaces, preferably OPC and OPC-UA.
• SQL Database Server proficiency; knowledge with SQL Database Cluster (Always ON) is a plus.
• Application Engineering experience with manufacturing control systems in a highly automated manufacturing environment.
• Knowledge of Computer System Validation (CSV) and Computer System Assurance (CSA).
• Familiarity with key Manufacturing IT trends such as Smart Buildings, Smart Manufacturing, Industrial IoT, and Cybersecurity.
• Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, and Data Integrity principles.

Nice-to-haves

• Entrepreneurial mindset e.g. 'automating automation'.