Principal Product Owner, Manufacturing Execution

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🕒 il y a 1 mois

🌲 North Carolina – Distant

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⏰ Temps Plein

🔴 Expert

✅ Responsable Produit

🗣️🇺🇸🇬🇧 Anglais requis

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Logo of FUJIFILM Corporation

FUJIFILM Corporation

10 000+ employés

Fondée en 1934

🏭 Fabrication

🏥 Santé

Manufacturing • Healthcare • Electronics

La FUJIFILM Corporation est une entreprise mondiale fondée en 1934, opérant dans divers domaines, y compris la santé, l'électronique et l'imagerie. En tant que société de santé intégrale, FUJIFILM développe un large éventail d'activités dans la prévention, le diagnostic et le traitement. De plus, l'entreprise met l'accent sur la durabilité environnementale grâce à une efficacité industrielle améliorée, tout en capturant et préservant les souvenirs par le biais du film et de la photographie, enrichissant les vies émotionnelles et les connexions humaines.

Description

• Own and evolve the product strategy and roadmap for manufacturing execution across all sites • Translate business needs into epics, features, and user stories with testable acceptance criteria and cGMP controls • Maintain a transparent, value-ranked backlog and manage dependencies across MES, DCS, interfaces, and plant networks • Lead Agile ceremonies for multiple scrum teams • Define the Definition of Done covering functional fit, Part 11/Annex 11, security, performance, and data integrity • Orchestrate UAT, validation documentation, release cutovers, and hypercare • Ensure audit readiness and support inspections • Represent shop-floor users and site leadership in product decisions • Drive decisions on recipe design, exception handling, review-by-exception, equipment states, and maintenance windows • Direct vendor teams and statements of work; track delivery performance • Manage small to moderate product budgets and business cases • Quantify value realization against committed outcomes • Define, track, and publish KPIs including lead time, yield, RFT, and downtime • Drive root-cause analysis and prevention • Standardize recipes and workflows and expand automated data capture • Contribute to network standards for MES recipe design, data models, and integration patterns • Ensure cybersecurity and segregation-of-duties controls with Automation and IT • Perform other duties as assigned

🎯 Exigences

• 12+ years of experience in biopharma manufacturing or industrial technology • 3+ years as a Product Owner, Product Manager, or Business Analyst delivering GxP shop-floor systems • Deep understanding of biologics drug substance operations, including seed train, bioreactors, harvest/clarification, chromatography, UF/DF, buffer/media preparation, and CIP/SIP • Experience with equipment readiness and maintenance on the shop floor • Leadership of multi-site MES/eBR initiatives using Syncade and/or PAS-X integrated with DeltaV • Working knowledge of ISA-88/95 and recipe orchestration • Agile delivery across multiple scrum teams and vendors • Proficiency with Jira or Azure DevOps • Excellent prioritization and stakeholder communication • Hands-on MES/eBR experience in regulated environments • Any combination of education and experience providing an equivalent background to deliver role expectations • Preferred: experience harmonizing multi-platform MES estates and establishing network standards • Preferred: exposure to e-logbooks/downtime tracking, site automation standards, OT networks, and cybersecurity constraints

🏖️ Avantages

• Benefits and compensation governed by the location of the employee’s home site • Global position supporting FUJIFILM Biotechnologies sites worldwide • Equal opportunities in hiring, promotion and advancement, compensation, benefits, and training • Reasonable accommodation during the application and selection process

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