Job Description:
• 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:
• 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:
• 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).