Kneat GX Consultant

Job description

Job Role: Kneat Gx Consultant **About the Role** Function Digital Validation / Validation Systems / GxP Platform Implementation Experience. The Consultant should independently perform Kneat Gx site implementations and related configuration work in a regulated GxP environment. The role converts site validation processes into compliant, scalable, reusable Kneat configurations by working with Quality, Validation, Engineering, IT, System Owners, Administrators, Workspace Managers, Power Users, and site SMEs. **Responsibilities** - Perform end-to-end site onboarding, readiness assessment, implementation planning, milestones, risks, go-live criteria, and transition to steady-state support. - Define implementation scope across CQV, CSV/CSA, AIQ, equipment qualification, process validation, cleaning validation, method validation, logbooks, and related processes. - Facilitate process discovery workshops, review site procedures/templates, map current-state processes to Kneat capabilities and define future-state digital validation workflows. - Identify standardization and reuse opportunities across disciplines, document types, templates, SGTs, object templates, and program packs. - Configure or support workspace structures, discipline maps, document types, folders, categorized documents, logs, object organization, naming conventions, and workspace access logic. - Create and maintain document templates, reusable content, section structures, section locks, properties, Section Group Templates, object template categories, object templates, and library properties. - Manage reviewer/approver assignments, workflow sequencing, mandatory/non-mandatory signatories, and electronic review/approval controls. - Configure equipment, system, requirement, and other entities; establish entity relationships, requirement traceability, RTM, cross-references, SPR tables, entity attributes, and Tag ID management. - Enable in-app RTM or equivalent reporting, document status visibility, and inspection-ready traceability outputs. - Define access model with System Administrator, including access groups, user groups, custom groups, folder access, collection access, and view-only needs. - Support configuration impact assessment, risk assessment, validation evidence, WPIV/process verification, change-control alignment, audit trail expectations, data integrity, and GxP compliance. - Deliver demonstrations, training, quick-reference guidance, configuration handover, knowledge transfer, hypercare, issue resolution, and post-go-live stabilization. **Qualifications** - 8-12+ years in pharma/biotech validation, GxP systems, or digital validation consulting; 5-8 years hands-on Kneat Gx preferred. **Required Skills** - Strong understanding of GxP, GMP, GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+ data integrity, electronic records, and electronic signatures. - Experience with CQV, CSV/CSA, AIQ, equipment qualification, process validation, cleaning validation, method validation, and related validation processes. - Ability to independently conduct process mapping and translate site requirements into Kneat configuration. - Strong stakeholder management across Quality, Validation, Engineering, IT, System Owner, System Administrator, vendors, and site teams. - Multi-site Kneat rollout experience across manufacturing sites or business units. - Experience with process harmonization, program packs, reusable validation content, audit readiness, inspection support, ServiceNow, LMS/SFLMS, change control, deviations, and enterprise support processes. **Preferred Skills** - Site implementation plan, readiness assessment, process maps, configuration design, and go-live checklist. - Workspace, discipline, document type, template, SGT, object template, approval workflow, entity, RTM, reporting, and access model configuration outputs. - Validation/configuration verification support, training material, handover package, hypercare notes, and stabilization support.