CPV Digitalization Consultant

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 (1015 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.

Requirements

Experience:

• 10+ years in pharmaceuticals, with a focus on CPV or related quality assurance processes.
• Hands-on experience with CPV implementation, preferably in digital environments.

Technical Skills:

• Proficiency with statistical tools (e.g., JMP, Minitab, SAS).
• Expertise in AI/ML applications for process monitoring (preferred).
• Knowledge of regulatory requirements for CPV.

Soft Skills:

• Strong analytical and problem-solving skills.
• Excellent communication skills to collaborate across teams.
• Ability to create clear, actionable documentation.

Benefits

We're on a Mission

In 2005, we disrupted the life sciences industry by introducing the world's first digital validation lifecycle management system. ValGenesis VLMS® revolutionized compliance-based corporate validation activities and has remained the industry standard.

Today, we continue to push the boundaries of innovation ? enhancing and expanding our portfolio beyond validation with an end-to-end digital transformation platform. We combine our purpose-built systems with world-class consulting services to help every facet of GxP meet evolving regulations and quality expectations.

The Team You'll Join

• Our customers success is our success. We keep the customer experience centered in our decisions, from product to marketing to sales to services to support. Life sciences companies exist to improve humanity's quality of life, and we honor that mission.?
• We work together. We communicate openly, support each other without reservation, and never hesitate to wear multiple hats to get the job done.
• We think big. Innovation is the heart of ValGenesis. That spirit drives product development as well as personal growth. We never stop aiming upward.
• We're in it to win it. We're on a path to becoming the number one intelligent validation platform in the market, and we won't settle for anything less than being a market leader.?

Qualification

Bachelor's Degree