Principal Product Owner, Manufacturing Execution

FUJIFILM Biotechnologies; Milwaukee (WI); On-site; USD 140,000 - 210,000; Full time

Job summary

FUJIFILM Biotechnologies seeks a Product Owner, Manufacturing Execution to shape the vision, roadmap, and delivery of production execution across a multi-site biologics network. You will orchestrate Agile delivery with internal and vendor teams, harmonize MES platforms (Syncade and PAS‑X) with DeltaV integration, and ensure compliant, right‑first‑time execution that improves yield and lead time.

This high‑impact role sits at the intersection of digital, operations, quality, and automation in a

Qualifications

• 12+ years in biopharma manufacturing or industrial tech with 3+ years as Product Owner/Manager delivering GxP shop-floor systems.
• Deep understanding of biologics DS operations and equipment readiness on the shop floor.
• Demonstrated leadership of multi-site MES/eBR initiatives integrated with DeltaV; ISA-88/95 knowledge.
• Agile delivery across multiple scrum teams and vendors; proficient in Jira/Azure DevOps.
• Hands-on MES/eBR in regulated environments; familiarity with Syncade and PAS X and ISA 88/95.

Responsibilities

• Own and evolve the product strategy and roadmap for manufacturing execution across all sites.
• Translate business needs into epics/features/user stories with testable acceptance criteria; maintain a transparent backlog and manage dependencies across MES, DCS, interfaces, and plant networks.
• Lead Agile ceremonies for multiple scrum teams; define DoD; orchestrate UAT, validation docs, release cutovers, and hypercare; ensure audit readiness for inspections.
• Act as the voice of shop-floor users and site leadership; drive decisions on recipe design, exception handling, and maintenance windows.
• Direct vendor teams and SOWs; track delivery performance; manage small to moderate product budgets and business cases; quantify value realization.
• Define, track, and publish KPIs (lead time, yield, RFT, downtime); standardize recipes/workflows; expand automated data capture.
• Contribute to network standards for MES recipe design, data models, and integration patterns; ensure cybersecurity and segregation-of-duties controls.

Skills

Agile delivery

Stakeholder communication

Leadership across sites

Vendor management

Regulatory understanding

Tools

Jira

Azure DevOps

Syncade

PAS-X

DeltaV

Job description

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. You’ll orchestrate Agile delivery with internal and vendor teams, harmonize MES platforms (Syncade and PAS‑X) with DeltaV integration (ISA‑88/95), and ensure compliant, right‑first‑time execution that measurably improves yield, lead time, and productivity.

This is a high-impact role at the intersection of digital, operations, quality, and automation—perfect for a product leader who thrives in GxP environments and loves turning complex challenges into scalable, audit‑ready solutions.

Company Overview

The work we do at FUJIFILM Biotechnologies has never been more important—and 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 people’s 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 70,000 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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What you’ll 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, 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); orchestrate UAT, validation documentation, release cutovers, and hypercare; ensure audit readiness and support inspections.
• Act as the voice of 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; 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 segregation‑of‑duties 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 multi‑site MES/eBR initiatives (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/Azure DevOps; excellent 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, which would provide an equivalent background to deliver against role expectations.

Preferred qualifications

• Proven experience harmonizing multi‑platform MES estates and establishing network standards; exposure to e‑logbooks/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.

This is a global position that will support all our FUJIFILM Biotechnologies sites. This position can be based at any of our locations around the globe. Benefits and compensation will be governed by the location that you are based from and considered your home site.

As part of any recruitment process, FUJIFILM Biotechnologies collects and processes personal data relating to job applicants. The organization is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations and may share this as part of the global recruitment process with hiring managers in Europe and the United States.

EEO Information

Fujifilm is committed to 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 ([e-mail]).