ValGenesis is expanding its digital validation solutions by incorporating Continued Process Verification (CPV) capabilities into our SaaS platform.

To achieve this, we are seeking a CPV Digitalization Consultant with expertise in statistical modeling, regulatory compliance, and emerging AI/ML technologies.

This role will inform product development, ensuring that our solution addresses the needs of manufacturing, quality assurance, and regulatory stakeholders.Engagement Structure: The consultants will be engaged on a milestone-driven basis rather than a fixed-term contract.

Engagement Type: Consultant Part-Time (10–15 hours per week, flexible schedule) Milestones: Each phase will have a clearly defined scope, deliverables, and timeline, agreed upon upfront.

Sequential Approval: After the successful completion of each milestone, we will evaluate their work and decide whether to proceed to the next milestone.

Flexibility and Control: This approach allows us to assess the value of their contributions iteratively, ensuring alignment with our goals before committing to further phases.

Maximum Duration: The engagement will not exceed six months, but milestone renewals provide flexibility based on performance and project needs.

Core Activities:Process Mapping and Requirement Gathering: Map CPV workflows, identifying critical quality attributes, performance metrics, and pain points.

Collaborate with manufacturing and quality teams to capture their data monitoring and compliance needs.

Regulatory Compliance Guidance: Ensure alignment with FDA, EMA, and ICH CPV guidelines.

Define audit-ready reporting features to maintain data integrity.

Predictive Analytics and Statistical Modeling: Design statistical models for trend analysis, anomaly detection, and batch failure prediction.

Recommend AI/ML solutions for predictive maintenance and real-time monitoring.

Technology Integration: Identify integration points with MES, LIMS, ERP, and other systems.

Provide future-proof recommendations for scalable, cloud-based CPV solutions.

Knowledge Management:Document workflows and reporting requirements, ensuring usability and scalability.