IT OT Manufacturing Systems Application Engineer

Roche•Hillsboro, OR

About The Position

The Opportunity 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 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. Key Responsibilities: End-to-End Accountability as a System Owner / Local Product Owner for Manufacturing IT Applications in a 24x7 Good Manufacturing Practice (GMP) environment. Procurement, development, integration, modification, operation, maintenance, validation, and retirement of the SCADA system (Primarily Rockwell FactoryTalk). Daily maintenance of 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. Maintenance of the validated state of the administered system(s) including lifecycle documentation updates, change management, and continuity management. Develop and maintain training for administered system(s). Determine and mitigate any risks associated with integration and/or upgrade of administered system(s). Coordinate with Global IT and local stakeholders to ensure compliance and address any impacts to the administered system(s). Execution and oversight of validation activities including validation planning, protocol authoring, and test execution to maintain a validated state. Perform system periodic maintenance (audit trail review, user access review, etc.). Perform user account auditing, provisioning, reset and activation for administered system(s). Work with Business Process Owners for the upgrade/patching and changes to the system to ensure GMP compliance. Creation and maintenance of 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 DeltaV. Represent and mitigate application dependencies as related global systems evolve their business processes and technologies (e.g. SAP upgrade & LIMS replacement). Determine business criticality and product quality requirements, and in collaboration with Delivery Service Managers, ensure appropriate service levels. 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. In collaboration with IT Business Partners, monitor and improve stakeholder and user experience and ensure strong support of Product Transfers and Make/Assess/Release. Support regulatory audits.

Requirements

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/or administration of Rockwell Automation control systems (FactoryTalk, ThinManager, Studio 5000, RSLogix).
Experience working with PLCs, HMIs, and manufacturing systems.
Knowledge of Manufacturing Execution System (Preferrably PharmaSuite), Distributed Control Systems (DeltaV), OSI PI Data Historian, LIMS, ERP etc.
Keep abreast of key Manufacturing IT trends and be curious - Smart Buildings, Smart Manufacturing, Industrial IoT, Manufacturing Digital Plant Maturity, Cybersecurity, Pharma 4.0, Data Integrity principles, technology, and data standardization, etc.
Nurtures and develops a business savvy consultative and value-driven partnership with key stakeholders.
Exhibits the behaviors of a Lean-Agile Leader with a Lean-Agile Mindset.
Expert-level knowledge of cGMP, GAMP5, and Data Integrity regulations within a Life Sciences context.
Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21 CFR Part 11,cGMP Annex 11, Data Integrity principles.
Strong understanding of industrial communication protocols (OPC UA/DA, EtherNet/IP) and Thin Client management (ThinManager)
Prior experience in working closely with IT OT providers/vendors.

Responsibilities

End-to-End Accountability as a System Owner / Local Product Owner for Manufacturing IT Applications in a 24x7 Good Manufacturing Practice (GMP) environment.
Procurement, development, integration, modification, operation, maintenance, validation, and retirement of the SCADA system (Primarily Rockwell FactoryTalk).
Daily maintenance of 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.
Maintenance of the validated state of the administered system(s) including lifecycle documentation updates, change management, and continuity management.
Develop and maintain training for administered system(s).
Determine and mitigate any risks associated with integration and/or upgrade of administered system(s).
Coordinate with Global IT and local stakeholders to ensure compliance and address any impacts to the administered system(s).
Execution and oversight of validation activities including validation planning, protocol authoring, and test execution to maintain a validated state.
Perform system periodic maintenance (audit trail review, user access review, etc.).
Perform user account auditing, provisioning, reset and activation for administered system(s).
Work with Business Process Owners for the upgrade/patching and changes to the system to ensure GMP compliance.
Creation and maintenance of 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 DeltaV.
Represent and mitigate application dependencies as related global systems evolve their business processes and technologies (e.g. SAP upgrade & LIMS replacement).
Determine business criticality and product quality requirements, and in collaboration with Delivery Service Managers, ensure appropriate service levels.
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.
In collaboration with IT Business Partners, monitor and improve stakeholder and user experience and ensure strong support of Product Transfers and Make/Assess/Release.
Support regulatory audits.