Sr Product Owner - CSV
Posted Updated
Description
Job Summary
Key Responsibilities
Basic Qualifications
Preferred Qualifications
Skills
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
The Senior Product Owner - CSV is responsible for leading and managing Computer System Validation (CSV) activities to ensure digital systems are compliant, validated, and fit for purpose throughout their lifecycle. The role works closely with business, quality, validation, and technology teams to translate business and regulatory requirements into compliant solutions, validation strategies, and prioritized deliverables. The role ensures adherence to CSV, Good Practice (GxP), data integrity, security, and regulatory requirements through effective validation planning, risk-based testing, change control, and lifecycle management. It also drives standardization, continuous improvement, and the adoption of AI-enabled and automated validation practices to improve efficiency, quality, and compliance. The Product Owner - CSV is accountable for validation strategy, compliance readiness, and validation lifecycle activities, ensuring systems remain reliable, compliant, and audit-ready while supporting business and operational objectives. The role contributes to product roadmap planning, backlog prioritization, and KPI (Key Performance Indicator) monitoring to drive continuous improvement and effective governance of the CSV/MES (Manufacturing Execution System) product portfolio.
Key Responsibilities
- Manage CSV requirements, validation deliverables, and compliance activities for MES systems.
- Own and manage CSV requirements, validation activities, risk assessments, testing, change controls, and release readiness to ensure 100% compliance with GxP, data integrity, security, and regulatory requirements.
- Ensure on-time delivery of validation documentation, test evidence, and approvals, maintain systems in a validated and audit-ready state throughout their lifecycle.
- Drive audit and inspection readiness, minimizing compliance observations and ensuring timely closure of audit findings, deviations, CAPAs (Corrective and Preventive Action), and change controls.
- Collaborate with business, quality, engineering, and site teams to deliver validated solutions that meet business objectives and regulatory expectations.
- Contribute to product roadmap planning and backlog prioritization, ensuring delivery aligns with compliance, operational, and business priorities.
- Monitor and improve key metrics including validation cycle time, compliance status, release readiness, system availability, roadmap delivery, and stakeholder satisfaction.
- Lead continuous improvement, standardization, and adoption of CSV best practices to increase efficiency, consistency, and compliance across MES platforms.
- Leverage AI and automation to improve validation efficiency, documentation quality, test execution, and compliance monitoring.
- Ensure systems remain reliable, compliant, available, and fit for purpose, supporting operational continuity and business performance.
Basic Qualifications
- Bachelor s or master s degree in computer science, Information Technology, Engineering, Business, Life Sciences or a related discipline, or equivalent relevant experience.
- Minimum 2-4 years of experience in CSV, validation, quality, business analysis or technology delivery within regulated manufacturing environments.
- Experience in managing CSV deliverables, including Validation Plans, Risk Assessments, User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Traceability Matrices, Test Protocols (IQ/OQ/PQ/UAT) Installation / Operational / Performance Qualification/User Acceptance Testing, Validation Reports and Change Controls.
- Experience in translating business and regulatory requirements into compliant, risk-based MES solutions.
- Experience in collaborating with Quality, Validation, Engineering, IT and business teams to maintain validated and audit-ready systems.
- Experience in GxP, data integrity, security and regulatory requirements, including use of AI and automation tools to support validation activities, documentation, testing and compliance monitoring.
- Experience in working with enterprise MES platforms in GxP-regulated pharmaceutical manufacturing environments.
Preferred Qualifications
- Experience in communication, facilitation and stakeholder management, including engaging business, quality, IT and validation stakeholders.
- Experience in facilitating requirements gathering, backlog prioritisation and solution reviews with stakeholders.
- Experience in applying analytical decision-making to balance business value, compliance, risk and operational impact.
- Experience in translating business and validation requirements into product priorities and validated solutions.
- Experience in MES, CSV, data integrity, security and GxP compliance requirements.
- Experience in maintaining documentation, traceability and lifecycle management records.
- Experience in working across cross-functional, global and vendor teams in a collaborative way.
- Experience in delivering solutions that meet compliance, user and business requirements.
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Skills
- Agile Methodology
- API Management
- CI/CD
- Cloud Based Services
- Computer Programming
- Configuration Management (CM)
- Containerization
- Database Management
- Infrastructure As Code (IaC)
- Microservices Architecture
- Network Security
- Operating Systems (OS)
- System Monitors
- Version Control System
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
