CSV Documentation and System Validation (Pharma)

Project overview

We are looking for an experienced subject matter expert for Computerized System Validation (CSV) in a pharmaceutical environment. You will support our team hands-on in carrying out and documenting CSV activities according to the Validation Master Plan and ensure compliance with regulatory requirements.

Your main tasks include the creation, review, and revision of CSV documents such as Validation Plans, User Requirement Specifications (URS), System Requirement Specifications (SRS), Functional Specifications (FS), Risk Analyses, Test Documentation, User Acceptance Tests (UAT), and Traceability Matrices. You will perform (re)qualifications and periodic reviews of computerized systems and document them according to GMP Annex 11. Furthermore, you will support the implementation of CAPA measures.

This is not a classic consulting role, but a hands-on position with a focus on documentation and ensuring GMP compliance.

We expect at least 5 years of experience in CSV in the pharmaceutical sector with comprehensive knowledge in the creation and review of CSV documents. You have in-depth regulatory knowledge in GMP, Annex 11, PIC/S, Data Integrity (ALCOA+), and 21 CFR Part 11. Experience with Periodic Reviews, CAPA measures, and authority approval processes is required.

You work independently, show high initiative, and are open to routine tasks. Thoroughly familiarizing yourself with SOPs and proactive problem-solving are your strengths.

Project details

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