ITOT Information Management Systems (IMS) Engineer

Are you passionate about Information (IT) and Automation Technology (OT) and aspiring to make a meaningful impact? Are you curious to shape a digital manufacturing architecture, ready to advance competitiveness on the market? This role may be for you!

We Make Medicines!

Behind every product sold by Roche is Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes lifesaving medicines at 11 locations, with the support of partners from around the world. Information (IT) and Automation Technology (OT) teams are key in producing and delivering medicine to patients. The organization is currently undergoing a transformation towards digitalization, advancing fundamental elements to meet future needs, such as using new technologies.

This position, based in Genentech's Hillsboro, Oregon facility, provides the opportunity to have a key role in a highly automated pharmaceutical drug substance facility. The site employs highly integrated computer control systems to manage plant operations and manufacturing data.

The Opportunity

You will support the Information Management System (IMS) System Owner in the administration and application of the IMS Systems to ensure the support of Product Transfers and Make/Assess/Release in a 24x7 Goods Manufacturing Practice (GMP) environment. As part of the Site Team and larger Global IT OT organization, you will also be expected to contribute to Manufacturing Operations Management initiatives and optimization/standardization of the global IT OT landscape.

This includes activities such as:

• Designing, planning, and deploying secure, optimized, reliable, and highly available PI System architectures

• Implement PI analytics with PI Asset Framework and Performance Equations

• Install and configuring Aveva / OSIsoft PI system for specific use cases including condition based maintenance, process optimization, process visualization, alarming and notification, and reporting

• Determine and mitigate any risks associated with integration and/or upgrade of the systems

• Host/guide/monitor vendors on site for activities related to administrated systems

• Validation activities including validation planning, protocol authoring, and test execution

• Support the Periodic System Audit Trail Review

• User account auditing, provisioning, resets and activation for the systems

• Support System Owner and 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 (Veeva, Condor, eVal Roche)

• Through Agile delivery model, provide technical expertise and local implementation experience as a member of Build and Run Squads.

• In collaboration with IT Business Partners, monitor and improve stakeholder and user experience and ensure strong support of Product Transfers and Make/Assess/Release.

• Participate in an after hours support and after hours on-call support rotation

Who You Are

• Bachelor's degree in Computer Engineering, Automation, Engineering or similar

• Minimum 3-6 years of experience in system and/or network administration

• Prefer experience in the life sciences Manufacturing domain

• Prior experience in working closely with IT OT providers/vendors

• Experience designing, planning, and deploying secure, optimized, reliable, and highly available PI System architectures

• Experience implementing PI analytics with PI Asset Framework and Performance Equations

• Experience installing and configuring Aveva / OSIsoft PI systems

• Experience working with PLC and DCS-based control systems and building management systems as data sources for the PI System

• Advanced analytical and troubleshooting skills with methodical approaches to solving difficult problems

• Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21 CFR Part 11,cGMP Annex 11, Data Integrity principles.

No relocation assistance will be provided for this position.

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.