Computerized System Validation (CSV) Specialist Pharma

Project overview

We are looking for an experienced CSV specialist to support the execution and documentation of validation activities for computerized systems in a pharmaceutical environment.

Your tasks include hands-on support of the entire CSV process with a focus on documentation and GMP compliance. You will be responsible for the creation, review, and revision of validation documents such as User Requirement Specifications (URS), System Requirement Specifications (SRS), Functional Specifications (FS), risk analyses, test documentation, User Acceptance Tests (UAT), Traceability Matrices, as well as validation and completion reports.

Furthermore, you will carry out the re-qualification and documentation of all computerized systems in accordance with GMP Annex 11 and support the implementation of CAPA measures. You will oversee Periodic Reviews and ensure that all systems comply with regulatory requirements.

We expect at least five years of experience in CSV in the pharmaceutical sector with comprehensive knowledge of GMP, Annex 11, PIC/S, data integrity (ALCOA+), and 21 CFR Part 11. You should have deep expertise in the creation and release of CSV documents and be proficient in Periodic Reviews and CAPA processes.

This is a hands-on specialist position for a self-reliant "craftsman" with high initiative. You work proactively, love documentation, and are willing to immerse yourself deeply in SOPs. Project management or classic consulting are not part of this role.

Project details

• Start: 30.11.2026
• Duration: 1 Jahr +
• Location: DE
• Languages: German