DeltaV System Owner

Genentech-posted 11 days ago
Full-time • Mid Level
Onsite • Hillsboro, OR
5,001-10,000 employees
Resume
Match Score
Upload and Match ResumeTrack Jobs with Teal

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 Opportunity 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 IT OT Team in Hillsboro is supporting Hillsboro Technical Operations (HTO) which is the commercial Make Assess and Release (MAR) and launch site for North America, and Hillsboro Innovative Therapies (HIT) which is transitioning into a multi-product facility for development, clinical and commercial supply capabilities for individualized and cell therapies. As a key member of the Hillsboro IT OT team, you will take on the System Ownership and local Product Ownership accountabilities for the Distributed Control System (DCS), specifically Emerson DeltaV, to ensure seamless support for Product Transfers and Make/Assess/Release activities in a 24x7 Goods Manufacturing Practice (GMP) environment. You will be the site's primary technical and compliance expert for the DeltaV platform, contributing to global IT OT optimization and standardization efforts. This include activities like:

  • Serve as the dedicated System Owner / Local Product Owner for the Emerson DeltaV Distributed Control System (DCS) and other designated Manufacturing IT Applications in a 24x7 Good Manufacturing Practice (GMP) environment.
  • Oversee the procurement, advanced development, integration, modification, operation, maintenance, validation, and decommissioning of the DeltaV DCS platform.
  • Lead Computer System Validation (CSV) efforts, including validation planning, protocol authoring, and test execution associated with owned systems.
  • Create, update, and maintain system lifecycle documents and procedures using document management systems (Veeva, Condor, eVal Roche), including System Descriptions, Design Specifications, and Disaster Recovery plans.
  • Responsibility for the Periodic System Audit Trail Review.
  • Support regulatory audits focusing on Process Control, Automation, and Data Integrity.
  • Represent and mitigate application dependencies as related global systems evolve their business processes and technologies (e.g., managing the interface points between DeltaV, MES, and IMS (AVEVA PI historian)).
  • Lead and coordinate negotiations with vendors on DeltaV-related activities, including licensing agreements, advanced support contracts, and lifecycle management.
  • Serve as the technical liaison for on-site vendor activities, overseeing installation, maintenance, and other services performed on administered systems.
  • Ensure reliable data integrity and connectivity between DeltaV and the PI Historian for long-term data retention and analysis.
  • Oversee the implementation and maintenance of user access controls, security patches, and network segmentation specific to the DeltaV ProfessionalPLUS and control network.
  • Oversee system backups, disaster recovery preparedness, and cybersecurity protocols in compliance with the ISA/IEC 62443 cybersecurity standards .
  • Through Agile delivery model, provide leadership, specialized DeltaV technical expertise, and local implementation experience as a member of Build and Run Squads.
  • Work to identify opportunities to optimize control strategies and improve business processes.
  • Review and triage ServiceNow tickets.
  • Provide expert-level troubleshooting and resolution for complex (DCS) system issues and technical inquiries as they arise during normal business hours, ensuring minimal disruption to operations and maintaining the integrity of critical automation systems .
  • Participate in an after hours on-call support rotation.
  • Bachelor’s degree in Computer Engineering, Automation Engineering or Equivalent experience.
  • Minimum 5+ years of hands-on experience implementing, configuring, and managing the Emerson DeltaV system in a GMP environment.
  • Minimum 3-6 years of experience in system and/or network administration.
  • Must have experience in the life sciences Manufacturing domain.
  • Prior experience in working closely with IT OT providers/vendors.
  • Strong attention to details and good problem-solving skills, with a demonstrated ability to think and solve problems at a system-level.
  • Expert-level knowledge of Emerson DeltaV DCS with a strong emphasis on application administration and engineering, including expertise in patching, upgrades, audit support, performance tuning, system and database log review and maintenance, specifically within manufacturing control systems.
  • System design and administration experience supporting multiple platforms and applications in cGMP-regulated environments, ensuring compliance and high system reliability.
  • Experienced with troubleshooting OT systems hardware.
  • Proficiency in Windows Server and Network Administration with specialization on DeltaV (DCS) proprietary communication protocols.
  • Specialized experience with industrial data exchange frameworks, including proficiency in classic OPC and OPC-UA protocols.
  • SQL Database Server proficiency.
  • In-depth knowledge of Good Manufacturing Practices (GMP) including familiarity with Health Authority regulations such as 21 CFR Part 11, EU Annex 11 and Global Data Integrity principles.
  • Knowledge of Pepperl and Fuchs Thin clients and DeltaV-supported infrastructure is a plus.
  • Knowledge of MQTT is a plus
  • Knowledge with SQL Database Cluster (Always ON), is a plus
Track Jobs with Teal

Job Search Resources

•
Resume Builder
•
Resume Examples
•
Cover Letter Examples

Tools

Career Hubs

Guides

Company

© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service