Principal Product Owner, Manufacturing Execution

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Take ownership and enhance the product strategy and roadmap for manufacturing execution across all locations.

• Convert business requirements into epics, features, and user stories that include testable acceptance criteria and cGMP controls.

• Maintain a clear, value-ranked backlog while overseeing dependencies among MES, DCS, interfaces, and plant networks.

• Facilitate Agile ceremonies for several scrum teams.

• Establish the Definition of Done that encompasses functional fit, Part 11/Annex 11, security, performance, and data integrity.

• Coordinate UAT, validation documentation, release cutovers, and hypercare processes.

• Ensure readiness for audits and assist during inspections.

• Advocate for shop-floor users and site leadership in product-related decisions.

• Make decisions on recipe design, exception handling, review-by-exception, equipment states, and maintenance windows.

• Manage vendor teams and statements of work; monitor delivery performance.

• Oversee small to moderate product budgets and business cases.

• Measure value realization against promised outcomes.

• Define, track, and report on KPIs such as lead time, yield, RFT, and downtime.

• Conduct root-cause analysis and implement preventive measures.

• Standardize recipes and workflows while expanding automated data capture.

• Contribute to network standards for MES recipe design, data models, and integration patterns.

• Ensure cybersecurity and segregation-of-duties controls in collaboration with Automation and IT.

• Perform additional duties as required.

⛳️ Requirements

• Over 12 years of experience in biopharma manufacturing or industrial technology.

• At least 3 years as a Product Owner, Product Manager, or Business Analyst focused on GxP shop-floor systems.

• Strong 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 production floor.

• Leadership in multi-site MES/eBR initiatives using Syncade and/or PAS-X integrated with DeltaV.

• Familiarity with ISA-88/95 and recipe orchestration.

• Agile delivery experience across multiple scrum teams and vendors.

• Proficient in Jira or Azure DevOps.

• Exceptional prioritization skills and stakeholder communication.

• Hands-on experience with MES/eBR in regulated environments.

• Any combination of education and experience that provides a comparable background to meet the role's expectations.

• Preferred: experience in harmonizing multi-platform MES estates and setting network standards.

• Preferred: familiarity with e-logbooks/downtime tracking, site automation standards, OT networks, and cybersecurity constraints.

🏝️ Benefits

• Benefits and compensation determined by the location of the employee’s home site.

• Global role supporting FUJIFILM Biotechnologies locations worldwide.

• Equal opportunities in hiring, promotion, advancement, compensation, benefits, and training.

• Reasonable accommodations provided during the application and selection processes.