Kneat Paperless Validation Consultant

About the role

Valspec is a global provider of system validation and lifecycle services, established in 1999, supporting life‑science clients with commissioning and qualification of computerized systems. The Kneat SME / Digital Validation Consultant will partner with Quality, Validation, Engineering, Manufacturing, and IT teams at a leading biopharmaceutical manufacturing facility in Pennsylvania to drive adoption, standardize processes, migrate qualification content, and establish best practices for a sustainable digital validation program using the Kneat platform.

Responsibilities

• 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.
• 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.
• 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, Risk Assessments, Installation Qualification (IQ), 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.
• 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.

Requirements

• 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, and 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

• Previous Kneat deployment or site expansion experience.
• Experience with Commissioning, Qualification, and Validation (CQV) programs.
• Experience supporting large capital projects or manufacturing facilities.
• Prior experience with ValGenesis, Veeva, ALM/Quality Center, TrackWise, MasterControl, or other validation and quality platforms.
• Experience creating and maintaining digital validation libraries and template structures.

Skills

• Outstanding communication and stakeholder management.
• Ability to lead discussions, influence decisions, and drive project deliverables.

Benefits

• Premium medical coverage
• 401(k) with company match
• Tuition reimbursement
• Unique performance incentives
• Employee Stock Ownership Plan (ESOP) – every team member has a stake in the company's success