CSV engineers

 2 X CSV engineers Needed High-level spec as follows:
 

1. two full-time CSV SMEs, each working 40 hours per week from 1 November 2026
2. SMEs will prepare, review, and progress CSV documentation through the required approval workflows.
3. Validation deliverables will be created in Kneat Gx, with supporting activities in Veeva, ServiceNow, and SharePoint.
4. The team will provide compliance guidance and support the execution and review of test scripts.
5. Expected documents include validation plans, requirements, designs, assessments, test plans, test scripts, change controls, reports, and release notes.
6. Deployment-ready packages must include templates, configuration guides, validation artifacts, OCM materials, training content, and handover documentation.
7. Candidates must have at least five years of pharmaceutical CSV experience and must have authored at least three full GxP validation packages.
8. Previous experience with CQV processes, agile delivery, and regulated manufacturing environments is requested.
9. Candidates must be proficient in English, work independently, manage competing priorities, and support US hours up to 7:00 p.m. EU time.

 
Will be 100% remote. Rates would be in line with the requested experience.