CSV Consultant

Job Title: CSV Kneat ConsultantLocation: RemoteJob Summary

We are looking for an experienced CSV /Kneat Consultant with strong hands-on experience with the Kneat Gx platform, preferably including the latest Kneat 26R1 release.

The ideal candidate will have a strong background in Computer System Validation (CSV) and technical documentation within a regulated Life Sciences, Pharmaceutical, Biotechnology, or Medical Device environment.

The resource will be responsible for developing, maintaining, and updating validation-related documentation, including Job Aids, Work Instructions (WIs), training presentations, and other technical/validation materials.

Hands-on experience working directly within Kneat and documenting validation processes is highly preferred.

Key Responsibilities

• Work hands-on with the Kneat Gx platform to support validation and documentation activities.
• Develop, maintain, and update Job Aids and Work Instructions (WIs).
• Create and maintain training presentations and user training materials.
• Document and maintain Computer System Validation (CSV) processes and deliverables.
• Translate complex validation processes and workflows into clear, easy-to-follow documentation.
• Support the creation, review, and maintenance of validation documentation within Kneat.
• Collaborate with CSV, Quality, IT, Validation, Business, and other project teams.
• Ensure documentation is accurate, consistent, traceable, and compliant with applicable quality and regulatory requirements.
• Support updates to documentation based on system changes, process improvements, and Kneat upgrades.
• Assist with validation documentation migration and/or process digitalization when required.
• Review existing documentation and identify opportunities for improvement.
• Support user training and knowledge-transfer activities.

Required Skills

• Strong hands-on experience with Kneat / Kneat Gx.
• Experience with Computer System Validation (CSV) or Computerized System Validation.
• Strong technical writing and documentation skills.
• Experience creating and maintaining:
  • Work Instructions
  • Job Aids
  • Training Presentations
  • Standard Operating Procedures (SOPs)
  • Validation Documentation
• Ability to understand and document validation workflows and processes.