Automation & MES Manager

Automation & MES ManagerBackground: The Manager of Automation & MES (Operational Technology (OT)) leads engineers, technical specialists, SMEs, and contractors responsible for OT controls across manufacturing and support equipment. This role oversees system integration, continuous improvement initiatives, and the full lifecycle of OT projects, ensuring compliance with regulatory requirements. The Manager represents the function during audits and is responsible for hiring, development, and performance management of the team.Key ResponsibilitiesDevelop and execute a site-wide OT strategy aligned with business objectives and operational excellence goalsEvaluate and deploy advanced automation technologies (robotics, MES, DeltaV, PAT, historian, reporting) to improve efficiency, quality, and safetyDrive adoption of systems through training, communication, and stakeholder engagementManage multi-year budgets, timelines, and cross-functional teams (engineering, program management, solution architecture)Support CAPEX planning and execution for site-wide OT initiativesDefine KPIs, dashboards, and governance frameworks to measure impactEnsure reliable day-to-day performance of automation systems, including troubleshooting and preventative maintenanceOversee OT network and process control infrastructure performance and issue resolutionLead validation of OT systems (CSV) and maintain systems in a validated stateExecute continuous improvement initiatives involving new equipment, technologies, and processesManage vendors, contractors, and internal resources for project deliveryMaintain and review technical documentation (drawings, P&IDs, specifications, validation protocols, change controls)Ensure compliance with FDA, cGMP, and other regulatory standardsServe as SME during internal/external audits and support nonconformance investigations, CAPA, and CQV activitiesRequired Experience & SkillsExperience with DCS/PLC systems (DeltaV, Allen Bradley, Siemens)HMI development and MES implementation/integrationKnowledge of OT communication protocolsAbility to interpret electrical schematics and P&IDsStrong understanding of controls engineering principles and standardsExperience managing CAPEX scope, schedule, and budgetsEducation & ExperienceB.S. or M.S. in Engineering (or equivalent experience)8+ years of automation and control systems experience within pharmaceutical, chemical, or medical device environments