Principal Product Owner, Manufacturing Execution

Jobtailor; Deutschland; Remote; EUR 110.000 - 150.000; Vollzeit

Zusammenfassung

Jobtailor is seeking a senior Product Owner/Manager to lead MES/global manufacturing execution initiatives. You will evolve the product strategy and translate business needs into epics, features, and user stories for GxP shop-floor systems across multiple sites.

You will drive agile ceremonies, define acceptance criteria, manage backlogs, and ensure audit readiness while coordinating with vendors and site leadership. This role demands deep MES/eBR experience and strong stakeholder communication.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Biopharma experience

Product Ownership

Agile leadership

Stakeholder communication

Prioritization

Team leadership

Tools

Jira

Azure DevOps

Syncade

PAS-X

DeltaV

Jobbeschreibung

• 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.

Highest-signal resume keywords

• Product Strategy Development
• GxP Compliance
• Agile Methodologies
• MES/eBR Systems Management
• Stakeholder Communication

Hard Skills

• Biopharma Manufacturing
• Recipe Orchestration
• Root-Cause Analysis
• KPI Tracking
• Data Integrity
• CGMP Controls
• Equipment Readiness
• User Acceptance Testing
• Validation Documentation
• Budget Management

Soft Skills

• Prioritization
• Leadership
• Communication

Industry Keywords

• Biologics Drug Substance Operations
• ISA-88/95
• Shop-Floor Systems
• Cybersecurity Controls
• OT Networks

Tools & Technologies

• Jira
• Azure DevOps
• Syncade
• PAS-X
• DeltaV