Director – Automation

🕒 il y a 1 mois

🦀 Maryland – Distant

🦀 Maryland – Remote

💵 $203 400 - $237 300 / an

⏰ Temps Plein

🔴 Expert

👔 Directeur

👻 Score fantôme 6%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Lonza

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1897

🧬 Biotechnologie

💊 Pharmaceutique

🏭 Fabrication

💰 €444 795 339 Post-IPO Debt - Lonza en 2023-11

Biotechnology • Pharmaceuticals • Manufacturing

Lonza est une organisation mondiale de développement et fabrication sous contrat (CDMO) et une entreprise de sciences de la vie basée en Suisse. Elle propose une gamme intégrée de services complets allant du développement et de la fabrication de médicaments biologiques et de petites molécules - y compris le développement de lignées cellulaires, le développement de procédés et d'analyses, la formulation et le conditionnement primaire, la fabrication de substances actives et de produits finis, ainsi que le soutien réglementaire/CMC. Les capacités de Lonza englobent la synthèse avancée et les API (y compris les HPAPI), la bioconjugaison et les ADC, des modalités spécialisées telles que les thérapies cellulaires et géniques, l'ARNm/LNP, les procédés microbiens, ainsi que les produits de capsules et d'ingrédients de santé. Fondée en Suisse en 1897, Lonza se décrit comme un pionnier et un leader mondial dans l'industrie CDMO et opère avec environ 20,000 collaborateurs sur cinq continents pour soutenir les clients pharmaceutiques et biotechnologiques.

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.

🎯 Exigences

• 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.

🏖️ Avantages

• 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).