Job Title: CSV Kneat Consultant
Location: Remote
Job 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.