Manufacturing IT OT Systems Application Engineer

The Position

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? Then this role might 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.

The Position:

As part of the Hillsboro IT OT team, you will report to the Manufacturing Systems Lead and take the System Ownership and local Product Ownership accountabilities for Manufacturing IT/OT Applications. You will 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.

Your Key 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. (LyoPlus, Ellab, WAGIT- Wireless Glove Integrity Testers, FIT - Filter Integrity Testers, and SRS - Site Reporting System)

• 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. This entails performing data collection from the deviations database on the past 3 year's worth of planned and unplanned events, review impact on system's validated state and draft 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 (Veeva, Condor, eVal Roche)

• Represent and mitigate application dependencies as related global systems evolve their business processes and technologies (e.g. SAP upgrade & LIMS replacement).

• Develop, maintain, and practice Disaster Recovery and backup/restore

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

Who You Are

Education/Experience

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

• Minimum 6-10 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

Technical Skills

• System administration and/or system design, supporting multiple platforms and applications in a cGMP environment

• Windows Server and Network Administration proficiency

• 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

• Computer System Validation (CSV) and Computer System Assurance (CSA)

• Keep abreast of key Manufacturing IT trends and be curious - Smart Buildings, Smart Manufacturing, Industrial IoT, Manufacturing Digital Plant Maturity, Cybersecurity, Pharma 4.0, Data Integrity principles, technology, and data standardization, etc.

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

• Entrepreneurial mindset e.g. "automating automation"

This position is not eligible for relocation.

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.