Principal Product Owner, Manufacturing Execution

Fujifilm

Job Location:

Durham County, NC - USA

Monthly Salary: Not Disclosed

Posted on: 3 days ago

Vacancies: 1 Vacancy

Job Summary

Position Overview

Fuel the future of biologics manufacturing. As the Product Owner Manufacturing Execution you will shape the vision roadmap and delivery of production execution across a multi-site biologics drug substance network. Youll orchestrate Agile delivery with internal and vendor teams harmonize MES platforms (Syncade and PASX) with DeltaV integration (ISA88/95) and ensure compliant rightfirsttime execution that measurably improves yield lead time and productivity.

This is a high-impact role at the intersection of digital operations quality and automationperfect for a product leader who thrives in GxP environments and loves turning complex challenges into scalable auditready solutions.

Company Overview

The work we do at FUJIFILM Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate mission-driven people like you who want to make a real difference in peoples lives.

Join FUJIFILM Biotechnologies and help make the next vaccine cure or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion energy and drive - what we call Genki.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description

What youll do

Own and evolve the product strategy and roadmap for manufacturing execution across all sites in partnership with solution architects and stakeholders.
Translate business needs into epics/features/user stories with testable acceptance criteria and cGMP controls; maintain a transparent valueranked 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); orchestrate UAT validation documentation release cutovers and hypercare; ensure audit readiness and support inspections.
Act as the voice of shopfloor users and site leadership; drive decisions on recipe design exception handling reviewbyexception equipment states and maintenance windows to minimize production impactaligned to reference architectures and standards.
Direct vendor teams and SOWs; track delivery performance; manage small to moderate product budgets and business cases; quantify value realization against committed outcomes.
Define track and publish KPIs (lead time yield RFT downtime); drive root-cause 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 segregationofduties controls with Automation/IT.
And other duties as assigned.

Minimum qualifications (must-have)

12 years of experience in biopharma manufacturing or industrial technology with 3 years as a Product Owner/Manager or Business Analyst delivering GxP shop-floor systems.
Deep understanding of biologics DS 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 multisite MES/eBR initiatives (Syncade and/or PASX) integrated with DeltaV; working knowledge of ISA88/95 and recipe orchestration.
Agile delivery across multiple scrum teams and vendors; proficiency with Jira/Azure DevOps; excellent prioritization and stakeholder communication.
Hands-on experience with MES/eBR in regulated environmentspreferably Syncade and/or PAS Xand integration with DeltaV DCS; working knowledge of ISA 88/95.
Any combination of education and experience which would provide an equivalent background to deliver against role expectations.

Preferred qualifications

Proven experience harmonizing multiplatform MES estates and establishing network standards; exposure to elogbooks/downtime tracking; familiarity with site automation standards OT networks and cybersecurity constraints.

Why youll 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.

Ready to make a measurable impact at scale Apply now and help us deliver rightfirsttime every time.

EEO Information

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement 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 etc.

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 ().

Required Experience:

Staff IC

Position OverviewFuel the future of biologics manufacturing. As the Product Owner Manufacturing Execution you will shape the vision roadmap and delivery of production execution across a multi-site biologics drug substance network. Youll orchestrate Agile delivery with internal and vendor teams harmo...