Senior Automation & Operational Technology Engineer

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The Senior Automation & Operational Technology (OT) Engineer is responsible for delivering technical leadership and hands-on support for site-based automation and Operational Technology (OT) systems. This is an Onsite position with the main site located in Walkersville, MD, with an expectation to support all of Walkersville's satellite offices. The role ensures the integrity, reliability, security, and compliance of OT infrastructure and industrial automation platforms across manufacturing, utilities, quality control, and laboratory environments.

Key systems supported include Environmental Monitoring Systems (EMS), Building Automation Systems (BAS), Process Control Systems (PCS), Manufacturing Execution Systems (MES/EBR), and Laboratory Information Management Systems (LIMS). The position supports system lifecycle management from design through validation, supports CAPEX/OPEX projects, and plays a role in ensuring data integrity, cybersecurity, and regulatory readiness in alignment with GMP, 21 CFR Part 11, and Annex 11 requirements.

Key Responsibilities:

• Support and maintain Automation/OT infrastructure including DCS, PCS, PLC, EMS, BAS, LIMS, MES/EBR, Recipe Management, and Batch Record systems.

• Program, configure, and support automation systems such as DCS and PLC platforms (e.g., DeltaV, Siemens, Allen Bradley).

• Troubleshoot and resolve complex Automation/OT issues related to hardware, control logic, system performance, and network communications.

• Administer OT networks and infrastructure, including virtualized servers, data storage, endpoint devices, IP/VLAN configurations, and network diagrams.

• Ensure Automation/OT system compliance with 21 CFR Part 11, Annex 11, GAMP, and internal quality standards.

• Support cybersecurity initiatives including system inventory, endpoint protection, remote access, network segmentation, and disaster recovery.

• Manage OT system administration tasks, including backups, patching, software updates, user management, and recovery procedures.

• Act as Subject Matter Expert (SME) for Automation/OT systems during audits, inspections, and regulatory engagements.

• Participate in quality investigations, including deviations, CAPAs, root cause analysis, and audit responses related to Automation/OT systems.

• Collaborate with engineering, IT, and vendors for installation planning, system upgrades, lifecycle management, and vendor assessments.

• Contribute to OT deliverables in CAPEX/OPEX projects, including system implementations, upgrades (e.g., EMS, PCS), and strategic site initiatives (e.g., Endo 2.0).

• Maintain accurate Automation/OT asset inventories and support disaster recovery testing and data integrity risk assessments.

• Assist in the development and review of documentation, including SOPs, system specifications, and work instructions related to OT.

• Deliver informal training and technical guidance to operators, maintenance, and engineering staff on Automation/OT systems and best practices.

• Provide on-call support and limited travel (up to 25%) to support operations across satellite sites.

Key Requirements:

• Bachelor’s degree in engineering, information systems, or related field preferred, with 5+ years of hands-on experience in OT or industrial automation in regulated manufacturing or lab settings.

• Proficient in control systems and automation platforms such as DeltaV, Rockwell FactoryTalk, Siemens, Allen Bradley, and MODA-ES.

• Skilled in SCADA, PLC, HMI, DCS, MES/EBR, EMS, BAS systems, and industrial communication protocols like Modbus, OPC, Ethernet/IP, and DeviceNet.

• Strong experience managing automation and controls projects across design, procurement, construction, validation, and operational phases.

• Familiar with regulatory and compliance standards such as 21 CFR Part 11, GAMP, GMP, Annex 11, IEC 62443, and NIST guidelines.

• Capable of developing URSs, technical specifications, control system drawings, and supporting CQV and continuous improvement efforts.

• Working knowledge of network infrastructure (VLANs, Cisco switching, firewalls, virtual environments) and relevant certifications (e.g., ISA/IEC 62443, Security+, vendor-specif