Director – Automation

This is a fully remote position, open to applicants in Maryland.

📋 Description

• Develop and implement the automation, digital systems, and operational technology (OT) strategy for a designated U.S. growth investment initiative focused on small molecule drug substance manufacturing.

• Act as the principal automation leader throughout the phases of facility design, construction, commissioning, qualification, validation, start-up, and operational transition, ensuring systems are dependable, compliant, scalable, and prepared to support GMP manufacturing from the outset.

• Oversee the automation workstream for the assigned U.S. growth investment project, guaranteeing alignment with project timelines, operational needs, and GMP standards.

• Establish the automation strategy, architecture, and digital manufacturing roadmap, encompassing control systems, system integration, data flows, historians, MES, and reporting solutions.

• Collaborate with Engineering, Manufacturing, MSAT, Quality, IT/OT, CSV, and EHS teams to ensure automation requirements are integrated into facility, process, and equipment design.

• Provide leadership for automation-related commissioning, qualification, computer system validation (CSV), and start-up readiness tasks.

• Manage automation vendors, system integrators, and external partners to ensure high-quality execution, timely delivery, and effective risk management.

• Ensure automation systems comply with regulatory, GMP, data integrity, cybersecurity, and lifecycle management standards.

• Identify and mitigate risks related to automation, digital, and operational technology while offering strategic advice to project leadership and governance teams.

• Develop the long-term automation support model, which includes organizational capability, training, knowledge transfer, and operational transition 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 field; advanced degree preferred.

• Over 12 years of experience leading automation, OT, or digital manufacturing projects within pharmaceutical, API, biotechnology, chemical, or other GMP-regulated manufacturing settings.

• Experience in supporting major capital investment projects, facility start-ups, greenfield or brownfield expansions, or large-scale manufacturing transformations.

• Profound knowledge of automation platforms, system integration, manufacturing execution systems (MES), SCADA/DCS/PLC technologies, and digital manufacturing solutions, as well as batch process control architectures.

• Proven experience in supporting small molecule drug substance or API, HPAPI, or complex chemical process manufacturing operations, including commissioning, qualification, validation, and readiness for commercial manufacturing.

• Strong understanding of GMP regulations, Computer System Validation (CSV), GAMP 5 principles, data integrity needs, and industrial cybersecurity standards.

• Demonstrated capability to lead cross-functional teams and influence stakeholders across Engineering, Manufacturing, Quality, IT/OT, MSAT, EHS, and Project Management organizations.

• Exceptional communication, strategic planning, vendor management, and problem-solving abilities, with experience presenting to senior leadership and project governance teams.

• Familiarity with ISA-88, ISA-95, and ISA/IEC 62443 frameworks, along with batch process automation.

• Experience in supporting multi-product API manufacturing or CDMO environments is preferred.

• Background in integrating DCS, PLC, MES, historians, and enterprise systems across intricate batch manufacturing facilities is preferred.

• PMP, GAMP, automation, or related technical certifications.

• Experience in supporting highly automated API, chemical, or small molecule manufacturing facilities.

• Willingness and capability to transition to an East Coast or Midwest U.S. site location as project demands evolve.

• Willingness and ability to travel to EMEA and NA 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, along with short-term and long-term disability insurance.

• Employee assistance programs.

• Paid time off (PTO).