Lead Engineer, MES – Digital Systems

🔥 11 horas atrás

🍂 Massachusetts – Remoto

🍂 Massachusetts – Remote

💵 $100.000 - $130.000 / ano

⏰ Tempo Integral

🟠 Sênior

🧑‍💻 Engenheiro Full-stack

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PerkinElmer

SiteLinkedInTodas as Vagas

5001 - 10000 funcionários

Fundada em 1938

🍽️ Alimentos e Bebidas

🏥 Saúde

💼 Consultoria

Food & Beverage • Healthcare • Consulting

A PerkinElmer é líder global no fornecimento de soluções analíticas e de testes para uma ampla gama de setores, incluindo o farmacêutico, a segurança de alimentos, a análise ambiental e os testes industriais. A empresa oferece equipamentos avançados e consumíveis, incluindo espectrômetros de massa, instrumentos de cromatografia e sistemas de espectroscopia. Com mais de 85 anos de experiência, a PerkinElmer é comprometida com a inovação e dedicada a fazer parceria com laboratórios em todo o mundo para impulsionar a descoberta científica e garantir a qualidade e a segurança de produtos. Seus serviços atendem setores como saúde, alimentos e bebidas, testes ambientais e aplicações industriais, ajudando os clientes a atender às exigências de conformidade e aos padrões de qualidade.

Descrição

• Develop system architectures and data flows for biologics, pharmaceutical, and advanced therapy manufacturing systems • Develop product recipe strategies across ERP, MES, and DCS Batch application layers • Define and control master data • Create ISA-88/ISA-95-aligned architecture and application/data-flow diagrams • Ensure scalability, cybersecurity, data integrity, and multi-product flexibility • Lead creation, review, and approval of URS, FRS, DS/DDS, functional and control narratives, recipe documentation, standards, and engineering guidelines • Translate process requirements into digital system design documents • Configure, program, and deploy digital systems in manufacturing environments • Develop, modify, and test MES, LIMS, Serialization, and CMMS functionality • Support integration of OEM skids and manufacturing equipment • Lead or support FAT, SAT, IQ/OQ, and PQ activities • Ensure changes comply with data integrity, change control, and validation lifecycle requirements • Lead deviation investigations, CAPAs, and risk assessments • Troubleshoot and optimize systems, analyze batch failures, and enhance performance • Support 24/7 operations through root cause analysis and issue resolution • Develop lifecycle plans for upgrades, patches, and system expansions • Collaborate with IT/OT, process engineering, MSAT, quality, and capital project teams • Manage vendors, system integrators, and OEMs • Mentor junior engineers and serve as technical SME during audits and regulatory inspections

🎯 Requisitos

• Bachelor’s Degree in Life Science, Engineering, or related discipline, or equivalent work experience • 4+ years / 7+ years in Digital Manufacturing Systems within GMP life sciences, including biotech, pharma, or ATMP • Expert-level experience with MES platforms, Data Repositories, Serialization, and integrations with ERP, LIMS, and CMMS • Deep knowledge of MES design, implementation, and lifecycle management • Ability to author, interpret, and lead URS, FRS, Functional Narratives, and system architecture documentation • Knowledge of ISA-88 and ISA-95 architecture • Knowledge of master data definition and control • Experience with eBR, RbE, eLogbooks, Equipment Tracking, and Weigh & Dispense functionality • Knowledge of FAT, SAT, IQ/OQ, and PQ protocols aligned with GAMP 5 and 21 CFR Part 11 • Experience with data integrity, change control, validation lifecycle, deviation investigations, CAPAs, and risk assessments • Willingness to travel as required for client project assignments • Strong communication and influencing skills across engineering, quality, IT/OT, and manufacturing • Advanced troubleshooting and problem-solving skills • Ability to manage multiple priorities in a high-pressure, regulated environment • Demonstrated leadership and mentorship abilities • Applicants must be authorized to work in the United States on a full-time basis • No current or future work visa sponsorship • Must have a valid driver's license

🏖️ Benefícios

• Full-time salaried position • Remote work in Massachusetts • Support from a global service network and distribution centers • Opportunity to contribute to life sciences projects across the full project lifecycle • Diverse, inclusive, and culturally diverse workforce • Equal opportunity employer