Principal Product Owner

Summary

We are seeking a Product Owner to drive the vision, roadmap, and backlog for production execution and maintenance in cGMP biologics (batch) manufacturing across four sites. This role focuses on functional outcomes (lead time, yield, productivity, right‑first‑time) and explicitly leverages the Solution Architects’ reference architecture for technical designs. The PO coordinates closely with Solution Architects to sequence capability design work and ensure delivery aligns with standards across Syncade MES, PAS‑X MES, and DeltaV DCS.

Key Responsibilities

• Product strategy and roadmap (functional)
  • Own the functional product vision and multi‑release roadmap for MES/DCS and maintenance execution; align to business goals, tech transfer, and site readiness.
  • Harmonize capabilities across Syncade/PAS‑X and DeltaV‑integrated recipes (ISA‑88, S-95) while adhering to architectural standards.
• Backlog ownership
  • Translate operational needs into epics/features/user stories with testable acceptance criteria and cGMP/data‑integrity requirements (ALCOA+).
  • Prioritize the backlog using value/risk methods (e.g., WSJF), balancing throughput, compliance, and technical debt in recipes, integrations, and workflows.
• Architecture collaboration and governance
  • Apply the enterprise/reference architecture provided by Solution Architects.
  • Partner with Solution Architects to:
    • Identify and prioritize architecture enablers, design spikes, and NFRs (performance, reliability, security, Part 11/Annex 11).
    • Schedule when capabilities require architected designs and sequence them within increments/releases.
    • Participate in architecture/design authority/ARB sessions; route changes through governance and change control.
    • Ensure solution designs, integration patterns, and standards are adopted consistently across sites and vendors.
  • Maintain a clear RACI: PO owns value and backlog; Solution Architects own technical design and reference patterns.
• cGMP delivery and validation
  • Lead Agile ceremonies for multiple scrum teams (internal and vendor); coordinate increments, releases, and cutovers across four sites.
  • Ensure definition of done includes functional fit, data integrity, e‑signatures/audit trails, security, performance, and traceability.
  • Orchestrate UAT, SOP/training updates, and hypercare; support inspections and audit readiness.
• Stakeholder engagement
  • Serve as the voice of Manufacturing, Maintenance, MSAT, Automation, and Site Leadership; drive decisions on master/recipe design, exception handling, and maintenance windows to minimize production impact.
• Data, integration, and automation (via architectural standards)
  • Guide functional requirements for automated data capture, equipment status, genealogy, and eBR; ensure implementations follow architected patterns between Syncade/PAS‑X and DeltaV.
• Maintenance scope
  • Own the backlog for shop‑floor maintenance execution (equipment readiness, calibration/PM visibility, equipment states, downtime tracking), coordinating closely with production; no enterprise EAM/QMS in scope.
• Continuous improvement and value realization
  • Define and track KPIs: lead time, yield, productivity, right‑first‑time; drive recipe/workflow standardization, review‑by‑exception, and reduction of manual interventions.

What this role is not

• Not responsible for defining enterprise or solution technical architecture.
• Does not approve deviations from reference architecture—escalates to Solution Architects/design authority.

No ownership of enterprise business systems (e.g., ERP/QMS).