Csv Consultant

**CSV Consultant**:

- Contract
- Onsite
- Hertfordshire, United Kingdom
- CQV
- 7000

**Overview
- A clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies based in the South West of the UK are seeking a CSV Consultant.

**Responsibilities
**Scope of Work**
- Delivery of IT/OT Network Qualification for New Site and OT Network Storage (S: Drive) Validation and Data Migration Qualification projects in terms of CSV
- Generating & Executing complete CSV Lifecycle documentation such as ( Creating Validation Plan, generating & Executing IQ,OQ,PQ, generating & executing Functional & Configuration specifications, support generating URS, Creating & Executing UAT, generating and executing Data Migration documents, generating Traceability matrix, generating report. Support drafting SOP).
- Working closely with IT Project Manager, SME, Validation Manager and Stake holders.
- Representing the client in key meetings with (IT/OT Network Qualification for New Site and OT Network Storage (S: Drive) Vendor to deliver the GxP projects.

**Qualifications
**Qualifications**:

- Intermediate to senior (7+ years) CSV (full lifecycle) experience.
- CSV experience of process equipment - Filling lines, Freeze Dryers / Lyos, vial washers & tunnels, cappers, autoclaves, parts washers, storage vessels, etc.
- Strong knowledge of regulations (GAMP®5 and 21 CFR Part 11, Annex 11) and modern CQV CSV practices
- Experience of working with software/automation validation in a project environment.
- A degree level in Engineering, or Science related area
- Hands on attitude, specifically functional testing of equipment outlined above.
- Excellent oral and written communication skills in English
- A high level of customer orientation/understanding