Associate Director, Maintenance

🕒 Julho 31

🦀 Maryland – Remoto

🦀 Maryland – Remote

💵 $174.000 - $203.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 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

• Lead maintenance and reliability readiness activities for a U.S. growth investment project. • Ensure the facility, equipment, utilities, process equipment, and maintenance systems are designed and implemented with long-term reliability, maintainability, mechanical integrity, and GMP compliance in mind. • Work closely with Engineering, Operations, Automation, MSAT, and Quality to establish the maintenance organization, systems, and processes required for successful site start-up and ongoing operations. • Provide maintenance and reliability leadership throughout facility design, construction, commissioning, qualification, and start-up activities. • Develop maintenance strategies, including preventive, predictive, and reliability-centered maintenance programs to support long-term asset performance. • Partner with Engineering and project teams to ensure maintainability, serviceability, accessibility, and lifecycle considerations are incorporated into facility and equipment design. • Establish asset lifecycle management strategies, including spare parts plans, calibration programs, and equipment reliability initiatives. • Support the selection, implementation, and optimization of CMMS and other maintenance technologies to enable effective planning and execution. • Participate in commissioning, qualification, FAT/SAT, and operational readiness activities to ensure maintenance requirements are incorporated and validated. • Define the future maintenance organization, including staffing plans, training requirements, operating procedures, and site support models. • Identify and mitigate equipment reliability, maintenance, and operational readiness risks while providing updates and recommendations to project leadership.

🎯 Requisitos

• Bachelor’s degree in engineering, Facilities Management, Reliability Engineering, or a related technical discipline; advanced degree preferred. • 10+ years of experience in maintenance, reliability, engineering, or technical operations within pharmaceutical or API manufacturing environments. • Experience with HPAPI, complex chemical synthesis, or chemical process manufacturing is preferred. • Experience supporting major capital projects, facility start-ups, manufacturing expansions, greenfield or brownfield investments, or large-scale operational readiness initiatives. • Strong knowledge of maintenance best practices, reliability engineering, asset lifecycle management, and equipment performance improvement. • Experience with CMMS platforms, predictive maintenance technologies, reliability-centered maintenance (RCM), and maintenance planning systems. • Understanding of GMP requirements related to equipment maintenance, calibration, qualification, documentation, and inspection readiness and mechanical integrity principles. • Demonstrated experience supporting small molecule drug substance, API, or HPAPI manufacturing operations preferred. • Experience supporting containment-intensive manufacturing environments (e.g., HPAPI containment, isolators, contained material handling) preferred. • Experience within a multi-product API manufacturing or CDMO environment is preferred. • Strong leadership, communication, collaboration, and problem-solving skills with the ability to influence cross-functional teams and stakeholders. • 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).