FUJIFILM Biotechnologies is seeking a Principal Product Owner for Manufacturing Execution to shape the MES vision across its manufacturing network. The role focuses on harmonizing Syncade and PAS-X with DeltaV to deliver audit-ready, right-first-time production that improves yield, lead time, and productivity. This position is based in Research Triangle Park, NC, with a hybrid work arrangement.
Responsibilities
- Own and evolve the manufacturing execution strategy and roadmap across all sites, partnering with solution architects and stakeholders to align with business goals.
- Translate business needs into epics, features, and user stories with measurable 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 (functional fit, Part 11/Annex 11, security, performance, data integrity); oversee UAT, validation documentation, release cutovers, and hypercare; ensure audit readiness and support inspections.
- Advocate for shop-floor users and site leadership; drive decisions on recipe design, exception handling, review-by-exception, equipment states, and maintenance windows to minimize production impact—aligned to reference architectures and standards.
- Direct vendor teams and SOWs; monitor delivery performance; manage small to moderate product budgets and business cases; quantify value realization against outcomes.
- Define, track, and publish KPIs (lead time, yield, RFT, downtime); conduct root-cause analysis and prevention; standardize recipes/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/IT.
- Other duties as assigned.
Requirements
- 12+ years of experience in biopharma manufacturing or industrial technology, with 3+ years as a Product Owner, Product Manager, or Business Analyst delivering GxP shop-floor systems.
- Deep understanding of biologics operations (seed train, bioreactors, harvest/clarification, chromatography, UF/DF, buffer/media prep, CIP/SIP) and equipment readiness/maintenance on the shop floor.
- Demonstrated leadership of multi-site MES/eBR initiatives (Syncade and/or PAS-X) integrated with DeltaV; working knowledge of ISA-88/95 and recipe orchestration.
- Agile delivery experience across multiple scrum teams and vendors; proficiency with Jira or Azure DevOps; strong prioritization and stakeholder communication.
- Hands-on experience with MES/eBR in regulated environments—preferably Syncade and/or PAS-X—and integration with DeltaV DCS; working knowledge of ISA-88/95.
- Any combination of education and experience that provides an equivalent background to fulfill role expectations.
Technologies
- Syncade
- PAS-X
- DeltaV
- ISA-88
- ISA-95
- Jira
- Azure DevOps
Preferred Qualifications
- Experience harmonizing multi-platform MES estates and establishing network standards; exposure to e-logbooks and downtime tracking; familiarity with site automation standards, OT networks, and cybersecurity constraints.
Why You’ll Love It Here
- Shape network-wide digital manufacturing capabilities with clear outcomes in yield, RFT, and cycle time.
- Lead meaningful change in a mission-driven, compliant environment where quality and innovation go hand in hand.
- Collaborate with world-class operations, quality, automation, and IT teams across sites and partners.
EEO Information
FUJIFILM is committed to providing equal opportunities in hiring, promotion, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national or social origin, disability, veteran status, or other protected characteristics.
ADA Information
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (fdbglobaltalent@fujifilm.com).
