Senior Automation Engineer, OT Infrastructure & Integration

Description

The company works across Innovative Medicine and MedTech to prevent, treat and cure complex diseases.

This is a People Leader role in Supply Chain Engineering, within Automation Engineering, based in Wilson, North Carolina, USA.

The role is the Automation Engineering Manager for OT Infrastructure & Integration and reports to the Site Automation organization.

You will set the direction and own delivery for manufacturing OT infrastructure and integrated automation across the site, including the strategy and operating model for systems that must be reliable, secure, compliant and scalable.

You will work with internal team members, suppliers, OEMs, system integrators, Digital/IT partners, automation system owners and other stakeholders on industrial networking, integration, historians, virtualization, cybersecurity and lifecycle work in a cGMP plant.

Responsibilities

• Set the strategy for manufacturing OT infrastructure and integration across the site and manage it through the full lifecycle.
• Lead, coach and develop internal engineers, contractors, suppliers, OEM teams and system integrators, setting technical direction, planning resources, governing delivery and aligning performance.
• Define and carry out the site's OT infrastructure and integration plan, covering industrial network design, server and virtualization platforms, historian infrastructure, system interfaces, cybersecurity controls, lifecycle standards and support models.
• Lead OT infrastructure projects from concept and detailed design through procurement support, build, FAT and integration testing, commissioning, qualification, start-up, handover, troubleshooting and ongoing support.
• Act as the technical authority for manufacturing OT infrastructure, making sure solutions are secure, reliable, scalable and maintainable and meet global automation, cybersecurity, Digital/IT and site standards.
• Lead all design and lifecycle work for virtualized servers, virtual machines, VLANs, network segmentation, domain services, authentication, backup, recovery and disaster recovery.
• Lead the integration of OT infrastructure with automation and manufacturing systems, including DCS/PAS, PLCs, SCADA/HMI, MES, BAS, historians, data platforms and Level 1, 2 and 3 systems.
• Create and maintain standards, templates, design specifications, network diagrams, interface definitions, support documents and lifecycle practices for OT infrastructure and integrated manufacturing systems.
• Review and approve designs, configurations, test records and turnover packages from suppliers, OEMs and system integrators against technical, compliance, cybersecurity and lifecycle requirements.
• Work with Automation, Manufacturing, Engineering, Quality, CSV, MES, BAS/Utilities, Lab Systems, Digital/IT, Cybersecurity and project leaders to agree requirements, resolve risks and deliver integrated site solutions.
• Make sure OT infrastructure deliverables meet cGMP, computerized system validation, data integrity, cybersecurity and site and global standards.
• Support inspections, risk assessments, investigations, deviations, CAPAs, change controls and remediation for OT infrastructure and integrated manufacturing systems.
• Manage scope, schedule, cost, quality, resources, dependencies and risks for OT infrastructure work packages, escalating key issues and decisions to project and business leaders.
• Define, track and report metrics on delivery, system performance, cybersecurity readiness, reliability, compliance and lifecycle health.
• Find and lead improvements that raise OT infrastructure reliability, system integration, cybersecurity, data availability, support and lifecycle efficiency.

Requirements

• Required: A minimum of a Bachelor's degree in Engineering, Computer Science, Science or a related technical field.
• Required: At least 6 years of progressive experience in manufacturing OT infrastructure, industrial automation infrastructure or closely related regulated manufacturing systems, with direct responsibility for OT architecture, implementation, integration, troubleshooting and lifecycle support.
• Required: Proven experience leading OT infrastructure or manufacturing integration work in a pharmaceutical, biopharmaceutical or other GMP-regulated plant.
• Required: Experience leading engineers, contractors, suppliers, OEM teams, vendors or system integrators, including owning technical direction, resource planning, issue resolution and delivery of OT infrastructure scope.
• Required: Strong knowledge of manufacturing OT architecture, including industrial networking, segmentation, virtualized servers, VLANs, communication paths, cybersecurity controls and infrastructure lifecycle management.
• Required: Experience designing, administering or supporting historian infrastructure, such as OSI PI or similar, and connecting historians to systems like DCS/PAS, MES, BAS, PLCs and data platforms.
• Required: Hands-on experience with OT network design, switch configuration and managing communication paths in a manufacturing setting.
• Required: Strong understanding of ISA-95 Level 1, Level 2 and relevant Level 3 systems, and how automation, OT infrastructure, MES, historians and site systems interact in a regulated architecture.
• Required: Strong communication, stakeholder management, organization and project execution skills, including defining requirements, coordinating cross-functional delivery, managing dependencies and tracking work packages.
• Required: Ability and willingness to travel internationally to suppliers, system integrators and the company's affiliate sites for technical training, knowledge transfer, FAT and integration testing and OT readiness work.
• Required: Experience that is only enterprise IT, process engineering, manufacturing operations, equipment engineering or validation, without substantial ownership of manufacturing OT infrastructure, does not meet this requirement.
• Preferred: Cisco experience.
• Preferred: Experience designing OT network architecture and industrial network solutions for pharmaceutical, biopharmaceutical or other GMP-regulated plants.
• Preferred: Familiarity with Emerson DeltaV or comparable DCS/PAS platforms, Werum PAS-X or comparable MES platforms, PLCs, BAS platforms, historians and their integrations.
• Preferred: Experience supporting greenfield or brownfield facility start-up, including automation, utilities, facilities, integration, commissioning and operational readiness.
• Preferred: Knowledge of domain controllers, Active Directory, authentication services, backup, recovery and disaster recovery in regulated OT environments.
• Preferred: Experience applying global engineering and cybersecurity standards and site or enterprise governance with multi-site or affiliate technical teams.
• Preferred: Experience supporting highly automated drug product, sterile or other complex GMP manufacturing.
• Preferred skills: Artificial Intelligence (AI), Business Alignment, Data Integration, Developing Others, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Lean Supply Chain Management, Machine Learning (ML), Management Systems Implementation, Process Improvements, Prototyping, Quality Assurance (QA), Robotic Automation, Science, Technology, Engineering, and Math (STEM) Application, Smart Systems, Team Management, Workflow Automation

Conditions

Full-time, on-site work at Wilson, North Carolina.

Design work happens at an engineering firm, with travel above 25% required until the project moves to the Wilson, NC plant.

International travel may be needed, and occasional short-term stays may be required during project execution and start-up.