Job Description : Validation Lead - Kneat Platform
Experience Level : 8-12 Years
Location : Multi-site (with coordination across global/regional sites)
Job Summary
We are seeking an experienced Kneat Platform Validation Lead to provide expert-level support for the implementation, validation, and harmonization of the Kneat Gx Platform across multiple sites. The role will be responsible for coordinating site-level implementations, managing external implementation partners, and ensuring consistent validation standards and compliance across the organization.
This role requires strong expertise in Computer System Validation (CSV), digital validation platforms (Kneat Gx), cross-functional coordination, and project management in regulated (GxP) environments.
Key Responsibilities
Kneat Platform Validation & Expertise
- Act as the subject matter expert (SME) for the Kneat Gx Platform, providing guidance on configuration, validation approach, and best practices.
- Lead and support CSV activities for Kneat, including risk assessment, lifecycle documentation, and validation deliverables.
- Ensure Kneat implementation aligns with GxP, data integrity, and regulatory requirements (e.g., FDA, EMA, MHRA).
Multi-Site Resource & Implementation Support
- Provide resource support to manage and coordinate Kneat activities across multiple sites.
- Plan, coordinate, and track site-level Kneat implementations, ensuring adherence to timelines and quality standards.
- Support sites through change management, onboarding, and adoption of the Kneat platform.
Project Management & Coordination
- Serve as Project Manager / Project Coordinator for Kneat global or regional rollout initiatives.
- Develop and manage project plans, milestones, dependencies, and risks for Kneat implementations.
- Facilitate cross-functional collaboration between Quality, IT, Validation, Engineering, and Operations teams.
Vendor Management
- Coordinate with external vendors / implementation partners for Kneat platform deployment.
- Oversee vendor deliverables, timelines, and quality of work.
- Act as the primary point of contact between internal stakeholders and external partners.
Validation Harmonization & Governance
- Lead efforts to harmonize validation approaches, templates, and processes across sites.
- Drive standardization of Kneat workflows, lifecycle models, and documentation.
- Ensure consistent inspection readiness and audit support across all participating sites.
Required Qualifications & Skills
Education
- Bachelor s degree in Engineering, Computer Science, Pharmacy, Life Sciences, or a related field.
Experience
- 8-12 years of experience in Computer System Validation (CSV) or digital validation within regulated (GxP) environments.
- Proven hands-on experience with the Kneat Gx Platform (implementation, validation, or administration).
- Experience managing multi-site global/regional projects.
- Demonstrated experience working with external vendors and implementation partners.
Technical & Domain Skills
- Strong understanding of GxP regulations, data integrity, and regulatory compliance.
- Expertise in validation lifecycle models, risk-based validation, and computerized system governance.
- Familiarity with pharma, biotech, or medical device manufacturing environments.
Soft Skills
- Strong project management, planning, and organizational skills.
- Excellent stakeholder management and communication abilities.
- Ability to influence, lead, and collaborate across diverse teams and cultures.
- Proactive, detail-oriented, and results-driven mindset.
Preferred Qualifications
- Experience leading enterprise-level Kneat rollouts.
- Certification in Project Management (PMP, PRINCE2) or Quality/Validation disciplines.
- Experience supporting regulatory inspections or audits involving validated systems.
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