MES System Owner

Genentech • Hillsboro, OR

2d

About 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? This role could 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 Opportunity As part of the Hillsboro IT OT team, you will report to the ITOT Infrastructure and Manufacturing Systems Lead and take the System Ownership and local Product Ownership accountabilities for the MES system and ensuring robust support for Product Transfers and Make/Assess/Release in a 24x7 Goods Manufacturing Practice (GMP) environment. As part of the Site Team and broader Global IT OT organization, you will contribute to Manufacturing Operations Management initiatives and optimization/standardization of the global IT OT landscape.

Requirements

• Bachelor’s Degree in Informatics, Engineering, or equivalent.
• Minimum of 6+ years of experience implementing and managing Manufacturing Systems solutions, preferably Rockwell PharmaSuite, or demonstrated experience that will facilitate rapid learning on the relevant platforms.
• Ability to participate in an on-call environment to meet business continuity requirements, including weekends and holidays if required.
• Experienced in the Biopharmaceutical or similar Manufacturing domains.
• Proficient in informational and operational technologies (IT/OT), with expertise in MES integration and interfaces to enterprise global systems.
• Knowledgeable about Manufacturing Execution Systems (Preferably PharmaSuite), LIMS, PI Data Historian, Quality Management Systems (Preferably Veeva and ValGenesis), ERP, etc.
• Familiar with new product introduction and manufacturing operations as they apply to all Manufacturing Systems.
• Exhibits the behaviors of a Lean-Agile Leader, with a Lean-Agile mindset.
• Knowledgeable of Good Manufacturing Practices (GMP), Health Authority practices, 21CFR Part 11, cGMP Annex 11, and Data Integrity principles.
• Experience with batch management and distributed control system.
• Experience with Microsoft SQL Server, SQL Scripting, and SQL Troubleshooting.
• Proven track record of working closely with IT/OT providers and vendors.

Responsibilities

• Serve as the System Owner / Local Product Owner for Manufacturing IT Applications in a 24x7 Good Manufacturing Practice (GMP) Pharmaceutical Manufacturing Facility.
• Oversee the entire system lifecycle of the MES system (Rockwell PharmaSuite), including procurement, design documentation, development, integration, modification, operation, maintenance, and retirement.
• Oversee computer systems qualification and validation.
• Address and mitigate global system application dependencies as global systems evolve their business processes and technologies (e.g., SAP upgrades, EDMS, LIMS integration).
• Collaborate with site Business Process Owners to manage system upgrades, patches, and changes, ensuring GMP compliance.
• Define business criticality and product quality requirements in partnership with Delivery Service Managers, ensuring appropriate service levels, disaster recovery procedures, governance, change management, compliance, and operational support.
• Lead or coordinate technical discussions and vendor negotiations.
• Utilize the Agile delivery model, providing leadership, technical expertise, and local implementation experience as a member of Build and Run Squads.
• Support inspection readiness for internal and external regulatory audits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees