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 Responsibilities
- Develop and execute a site-wide OT strategy aligned with business objectives and operational excellence goals
- Evaluate and deploy advanced automation technologies (robotics, MES, DeltaV, PAT, historian, reporting) to improve efficiency, quality, and safety
- Drive adoption of systems through training, communication, and stakeholder engagement
- Manage multi-year budgets, timelines, and cross-functional teams (engineering, program management, solution architecture)
- Support CAPEX planning and execution for site-wide OT initiatives
- Define KPIs, dashboards, and governance frameworks to measure impact
- Ensure reliable day-to-day performance of automation systems, including troubleshooting and preventative maintenance
- Oversee OT network and process control infrastructure performance and issue resolution
- Lead validation of OT systems (CSV) and maintain systems in a validated state
- Execute continuous improvement initiatives involving new equipment, technologies, and processes
- Manage vendors, contractors, and internal resources for project delivery
- Maintain and review technical documentation (drawings, P&IDs, specifications, validation protocols, change controls)
- Ensure compliance with FDA, cGMP, and other regulatory standards
- Serve as SME during internal/external audits and support nonconformance investigations, CAPA, and CQV activities
Required Experience & Skills
- Experience with DCS/PLC systems (DeltaV, Allen Bradley, Siemens)
- HMI development and MES implementation/integration
- Knowledge of OT communication protocols
- Ability to interpret electrical schematics and P&IDs
- Strong understanding of controls engineering principles and standards
- Experience managing CAPEX scope, schedule, and budgets
Education & Experience
- B.S. or M.S. in Engineering (or equivalent experience)
- 8+ years of automation and control systems experience within pharmaceutical, chemical, or medical device environments