Kneat SME​/Digital Validation Consultant

seeking an experienced Kneat Subject Matter Expert (SME) to support a major digital validation initiative at a leading biopharmaceutical manufacturing facility in Pennsylvania.

This role is ideal for a consultant who has successfully implemented, administered, or expanded Kneat within regulated GxP environments and is passionate about helping organizations transition from traditional paper-based validation processes to sustainable digital validation programs.

You will serve as the primary Kneat expert, partnering with Quality, Validation, Engineering, Manufacturing, and IT teams to drive adoption, standardize processes, migrate existing qualification content, and establish best practices for long-term success.

What You'll DoKneat Leadership & Deployment

• Act as the site SME for the Kneat platform and paperless validation processes.
• Lead or support Kneat implementations, enhancements, and expansion initiatives.
• Develop and execute deployment strategies, governance models, and adoption plans.
• Facilitate workshops and collaborate with stakeholders to define business and validation requirements.
• Drive continuous improvement of digital validation processes.

Content Conversion & Digital Validation

• Convert existing qualification, commissioning, validation, and lifecycle documentation into Kneat.
• Develop reusable templates, libraries, workflows, and document structures.
• Configure and optimize approval workflows, execution processes, and traceability within the platform.
• Support document execution, review, approval, and closure activities.

CSV & Compliance

• Lead Computer System Validation (CSV) activities associated with Kneat and related validation technologies.
• Develop and review validation deliverables including:
• Validation Plans
• User Requirements Specifications (URS)
• Functional Specifications
• Operational Qualification (OQ)
• Traceability Matrices
• Validation Summary Reports
• SOPs and Work Instructions
• Ensure compliance with GxP regulations, 21 CFR Part 11, Data Integrity requirements, and industry best practices.

Training & Change Management

• Train end users, power users, validation engineers, and quality personnel.
• Provide ongoing support and troubleshooting for Kneat users.
• Mentor cross-functional teams on paperless validation methodologies.
• Promote user adoption and long-term sustainability of digital validation processes.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related discipline.
• 5+ years of Computer System Validation (CSV), CQV, Validation, or Quality Systems experience in the pharmaceutical, biotech, or medical device industry.
• Hands-on Kneat experience as an administrator, author, reviewer, approver, or implementation lead.
• Experience supporting paperless validation initiatives in regulated GxP environments.
• Strong understanding of:
• GAMP 5
• ASTM E2500
• 21 CFR Part 11
• Data Integrity principles
• Software Development Lifecycle (SDLC)
• Experience developing and executing validation protocols and risk assessments.
• Outstanding communication and stakeholder management skills.
• Ability to lead discussions, influence decisions, and drive project deliverables.

Preferred Qualifications

• Experience with Commissioning, Qualification, and Validation (CQV) programs.
• Experience supporting large capital projects or manufacturing facilities.
• Prior experience with Val Genesis, Veeva, ALM/Quality Center, Track Wise, Master Control, or other validation and quality platforms.
• Experience creating and maintaining digital validation libraries and template structures.