Principal Product Owner, Manufacturing Execution

Stellenbeschreibung:

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

Requirements

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

Core Competencies

Demonstrates expertise in product strategy and roadmap development for manufacturing execution, with a strong focus on GxP compliance, Agile methodologies, and stakeholder communication. Proficient in managing MES/eBR systems and ensuring audit readiness in biopharma manufacturing environments.