Location: Hillsboro,OR, USA
Are you passionate about Information (IT) and Automation Technology (OT) and aspiring to make ameaningful impact? Are you curious to shape a digital manufacturing architecture, ready to advancecompetitiveness on the market?
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 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.
The Opportunity
As part of the Hillsboro IT OT team, you will take on System Ownership and local Product Ownership accountabilities for Manufacturing IT/OT Applications and 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.
Responsibilities include:
Responsible for the overall procurement, development, integration, modification, operation, maintenance, validation, and retirement of site specific OT systems. (IMS, AVEVA PI - Information Management System)
Troubleshoot immediate system issues, and inquiries as they arrive during normal business hours.
Participate in an after hours on-call support rotation
Update System lifecycle documentation, as the need arises, for all systems.
Perform System Maintenance and Lifecycle activities.
Develop and maintain training for administrated systems
Host/guide/monitor vendors on site for activities related to administrated systems
Validation activities including validation planning, protocol authoring, and test execution
Responsibility for the Periodic System Audit Trail Review
User account auditing, provisioning, resets and activation for all IT and OT systems
Develop and maintain user access request/approval workflow process 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
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
Lead or coordinate technical discussions and vendor negotiations.
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 experience
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
Technical Skills
System administration and/or system design, supporting multiple platforms and applications in a cGMP environment
Experienced with troubleshooting OT systems hardware and software
AVEVA or OSI PI software administration
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
Computer System Validation (CSV) and Computer System Assurance (CSA)
Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21 CFR Part 11,cGMP Annex 11, Data Integrity principles
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.