Director, Automation

Lonza•Walkersville, MD

2d•$203,400 - $237,300•Remote

About The Position

We are seeking a Director, Automation Lead to develop and execute the automation, digital systems, and operational technology (OT) strategy for an assigned U.S. growth investment project supporting small molecule drug substance manufacturing. This role serves as the primary automation leader throughout facility design, construction, commissioning, qualification, validation, start-up, and operational handover, ensuring systems are reliable, compliant, scalable, and ready to support GMP manufacturing from day one.

Requirements

Bachelor's degree in Automation Engineering, Electrical Engineering, Computer Science, Chemical Engineering, Life Sciences Engineering, or a related technical discipline; advanced degree preferred
12+ years of experience leading automation, OT, or digital manufacturing initiatives within pharmaceutical, API, biotechnology, chemical, or other GMP-regulated manufacturing environments
Experience supporting major capital investment projects, facility start-ups, greenfield or brownfield expansions, or large-scale manufacturing transformations
Strong knowledge of automation platforms, system integration, manufacturing execution systems (MES), SCADA/DCS/PLC technologies, and digital manufacturing solutions, and batch process control architectures
Demonstrated experience supporting small molecule drug substance or API, HPAPI, or complex chemical process manufacturing operations, including commissioning, qualification, validation, and commercial manufacturing readiness
Strong understanding of GMP regulations, Computer System Validation (CSV), GAMP 5 principles, data integrity requirements, and industrial cybersecurity standards
Proven ability to lead cross-functional teams and influence stakeholders across Engineering, Manufacturing, Quality, IT/OT, MSAT, EHS, and Project Management organizations
Excellent communication, strategic planning, vendor management, and problem-solving skills, with experience presenting to senior leadership and project governance teams
Experience with ISA-88, ISA-95, and ISA/IEC 62443 frameworks, and batch process automation
Ability and willingness to transition to an East Coast or Midwest U.S. site location as project needs evolve

Nice To Haves

Experience supporting multi-product API manufacturing or CDMO environments is preferred.
Experience integrating DCS, PLC, MES, historians, and enterprise systems across complex batch manufacturing facilities is preferred.
PMP, GAMP, automation, or related technical certifications
Experience supporting highly automated API, chemical, or small molecule manufacturing facilities

Responsibilities

Lead the automation workstream for an assigned U.S. growth investment project, ensuring alignment with project milestones, operational requirements, and GMP expectations
Define the automation strategy, architecture, and digital manufacturing roadmap, including control systems, system integration, data flows, historians, MES, and reporting solutions
Partner with Engineering, Manufacturing, MSAT, Quality, IT/OT, CSV, and EHS teams to ensure automation requirements are incorporated into facility, process, and equipment design
Provide leadership for automation-related commissioning, qualification, computer system validation (CSV), and start-up readiness activities
Manage automation vendors, system integrators, and external partners to ensure quality execution, on-time delivery, and effective risk management
Ensure automation systems meet regulatory, GMP, data integrity, cybersecurity, and lifecycle management requirements
Identify and mitigate automation, digital, and operational technology risks while providing strategic recommendations to project leadership and governance teams
Establish the long-term automation support model, including organizational capability, training, knowledge transfer, and operational handover to the future site team