Director – Automation

🕒 6 dias atrás

🦀 Maryland – Remoto

🦀 Maryland – Remote

💵 $203.400 - $237.300 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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Lonza

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1897

🧬 Biotecnologia

💊 Farmacêutico

🏭 Manufatura

💰 $444.795.339 Post-IPO Debt - Lonza em 2023-11

Biotechnology • Pharmaceuticals • Manufacturing

A Lonza é uma organização global de desenvolvimento e fabricação contratada (CDMO) e uma empresa de ciências da vida sediada na Suíça. Ela oferece soluções integradas de ponta a ponta em desenvolvimento e fabricação de medicamentos biológicos e de pequenas moléculas — incluindo desenvolvimento de linhagens celulares, desenvolvimento e análise de processos, formulação e embalagem primária, fabricação de substâncias e produtos farmacêuticos, e suporte regulatório/CMC. As capacidades da Lonza abrangem síntese avançada e APIs (incluindo HPAPIs), bioconjugação e ADCs, modalidades especializadas como terapias celulares e gênicas, mRNA/LNP, processos microbianos, e produtos de cápsulas e ingredientes para saúde. Fundada na Suíça em 1897, a Lonza se descreve como pioneira e líder mundial na indústria de CDMO e opera com cerca de 20. 000 colaboradores em cinco continentes para apoiar clientes farmacêuticos e biotecnológicos.

Descrição

• 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.

🎯 Requisitos

• 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.

🏖️ Benefícios

• 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).