MES System Owner

Job Title: MES System Owner
Location: Hillsboro, OR 97124
Duration: 12+ Months (Possibilities of Extension)

The position:
A healthier future. It’s what drives us to innovate.
To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come.
Creating a world where we all have more time with the people we love. That’s what makes us ***.
Client, a member of the group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to Client and develop medicines for people with serious and life-threatening diseases.
To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society.
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.
What you’ll do:

• 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.
• Identify opportunities to add value by improving business processes and enhancing patient outcomes through standardized technologies across sites.
• 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.

Who You Are:

• 24x7 support, 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.
• Stays updated with key trends in Manufacturing IT, and maintains curiosity about Industrial IoT, Manufacturing Digital Plant Maturity, Cybersecurity, Pharma 4.0, Data Integrity principles, Technology, and data standardization, among other topics.
• 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.
• Holds a Bachelor’s Degree in Informatics, Engineering, or equivalent.
• Has a minimum of 5+ years of experience implementing and managing Manufacturing Systems solutions, preferably Rockwell PharmaSuite, or demonstrated experience that will facilitate rapid learning on the relevant platforms.
• Experience with batch management and distributed control system.
• Experience with Microsoft SQL Server, SQL Scripting, and SQL Troubleshooting.
• Must have experience in the life sciences Manufacturing domain.
• Proven track record of working closely with IT/OT providers and vendors.