Kneat Paperless Validation Consultant

Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec’s mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals. Valspec’s projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies. Kneat SME / Digital Validation Consultant Location: Pennsylvania (Hybrid/Onsite Preferred) Company: Valspec Industry: Life Sciences | Biopharmaceutical Manufacturing Join Valspec and Help Transform Digital Validation Valspec is 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 Do Kneat 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 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…