Director – Automation

Lonza

Director of Automation developing automation strategy for small molecule drug manufacturing projects. Leading cross-functional teams and ensuring compliance in a GMP environment.

Posted 7/31/2026full-timeRemote • Maryland • 🇺🇸 United StatesLead💰 $203,400 - $237,300 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in automation strategy, digital manufacturing solutions, and operational technology within GMP-regulated environments, with a strong focus on leading cross-functional teams and managing complex projects. Proficient in automation platforms, system integration, and compliance with regulatory standards.

Highest-signal resume keywords

Automation Strategy DevelopmentGMP Compliance ExpertiseCross-Functional Team LeadershipSystem Integration and MES KnowledgeProject Management Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Automation EngineeringDigital Manufacturing SolutionsManufacturing Execution Systems (MES)SCADA/DCS/PLC TechnologiesBatch Process Control ArchitecturesComputer System Validation (CSV)Data Integrity RequirementsIndustrial Cybersecurity StandardsCommissioning and QualificationGAMP 5 Principles

Soft Skills

Excellent CommunicationStrategic PlanningVendor ManagementProblem-Solving Skills

Tools & Technologies

ISA-88 FrameworkISA-95 FrameworkISA/IEC 62443 FrameworkDCS IntegrationPLC IntegrationHistoriansEnterprise Systems

Certifications & Qualifications

PMP CertificationGAMP CertificationAutomation Certifications

Industry Keywords

Pharmaceutical ManufacturingAPI ManufacturingBiotechnologyChemical ManufacturingGMP-Regulated EnvironmentsSmall Molecule Drug Substance

Tech Stack

Tools & technologies

Cyber SecurityPMP

About the role

Key responsibilities & impact

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.
Serve 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.
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.

Requirements

What you’ll need

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.
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.
Ability and willingness to transition to an East Coast or Midwest U.S. site location as project needs evolve.
Willingness and ability to travel to EMEA and NA at approximately 25-30% of the time to meet business objectives.

Benefits

Comp & perks

Performance-related bonus.
Medical, dental and vision insurance.
401(k) matching plan.
Life insurance, as well as short-term and long-term disability insurance.
Employee assistance programs.
Paid time off (PTO).