IT OT Manufacturing Systems Application Engineer

Opportunity Overview

As part of the Hillsboro IT OT team, you will report to the Manufacturing Systems Operations 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 Good Manufacturing Practice (GMP) environment, and contribute to Manufacturing Operations Management initiatives and optimization/standardization of the global IT OT landscape.

• End-to-end accountability as a System Owner / Local Product Owner for Manufacturing IT Applications in a 24x7 GMP environment.
• Procure, develop, integrate, modify, operate, maintain, validate, and retire the SCADA system (primarily Rockwell Factory Talk).
• Daily maintenance of the administered system(s) including incident response, system troubleshooting, support requests, system health monitoring, access requests, and general inquiries.
• Participate in an after‑hours on‑call support rotation.
• Maintain the validated state of the administered system(s) with lifecycle documentation updates, change management, and continuity management.
• Develop and maintain training for the administered system(s).
• Determine and mitigate risks associated with integration and/or upgrade of the administered system(s).
• Coordinate with Global IT and local stakeholders to ensure compliance and address any impacts to the administered system(s).
• Execute and oversee validation activities including validation planning, protocol authoring, and test execution.
• Perform periodic system maintenance such as audit trail review and user access review.
• Perform user account auditing, provisioning, reset, and activation for the administered system(s).
• Work with Business Process Owners for upgrades, patching, and changes to maintain GMP compliance.
• Create and maintain system lifecycle documents and procedures using document management systems (Veeva, Condor, eVal Roche).
• Collaborate with Business Process Owners to align SCADA operations with upstream/downstream systems like SAP, LIMS, and Delta
  
  V.
• Represent and mitigate application dependencies as global systems evolve (e.g., SAP upgrade & LIMS replacement).
• Determine business criticality and product quality requirements, and collaborate with Delivery Service Managers to ensure appropriate service levels.
• Develop, maintain, and practice disaster recovery and backup/restore.
• Lead or coordinate technical discussions and vendor negotiations.
• Provide leadership, technical expertise, and local implementation experience as part of Build and Run Squads under an Agile delivery model.
• Monitor and improve stakeholder and user experience, ensuring strong support of Product Transfers and Make/Assess/Release.
• Support regulatory audits.

• Bachelor’s degree in Informatics, Engineering, or equivalent.
• 7+ years of experience implementing and/or managing SCADA systems, PLCs, and HMIs (Rockwell/Allen Bradley, Siemens).
• Biopharmaceutical or similar manufacturing domain knowledge.
• Experience designing, configuring, supporting, and administering Rockwell Automation control systems (Factory Talk, Thin Manager, Studio 5000, RSLogix).
• Experience working with PLCs, HMIs, and manufacturing systems.
• Knowledge of Manufacturing Execution System (preferably Pharma Suite), Distributed Control Systems (Delta
  
  V), OSI PI Data Historian, LIMS, ERP, etc.
• Knowledge of key manufacturing IT trends (Smart Buildings, Smart Manufacturing, Industrial IoT, Manufacturing Digital Plant Maturity, Cybersecurity, Pharma 4.0, Data Integrity principles, technology, and data standardization).
• Evidence of business‑savvy consultative partnership with key stakeholders.
• Lean‑Agile leadership behaviors and mindset.
• Expert knowledge of cGMP, GAMP5, and Data Integrity regulations within a Life Sciences context.
• Knowledge of GMP, Health Authority practices, 21 CFR Part 11, cGMP Annex 11, Data Integrity principles.
• Strong understanding of industrial communication protocols (OPC UA/DA, Ether Net/IP) and Thin Client management (Thin Manager).
• Prior experience working closely with IT OT providers/vendors.

The expected salary range for this position…