CSV Expert (Pharma)

Project overview

Hands-on support for the execution of CSV activities according to the VMP (Validation Master Plan) and review/validation of computerized systems according to the newly introduced CSV framework.

(Re)qualification and documentation (Periodic Reviews) of all computerized systems (production systems, software, devices with control or data processing) according to GMP Annex 11 and subsequent implementation of CAPA measures.

Creation, review, and revision of CSV documents, for example:

Validation Plans

User Requirement Specifications (URS)

System Requirement Specifications (SRS)

Functional Specifications (FS)

Risk Analyses

Test Documentation

User Acceptance Tests (UAT)

Traceability Matrices

Validation and Completion Reports.

Not a classic consulting role, but a hands-on role driving the CSV process, especially regarding documentation, while ensuring GMP compliance.

Essentially, getting everything related to computer systems onto paper, meaning every device in operation must be validated according to CSV. The main task is documentation!

Requirements

Min. 5 years of experience in CSV (Computerized System Validation) in the PHARMA environment, including many years of experience in the creation/review/release of CSV documents (SRS, FS, IQ, FT, UAT, risk analyses, traceability, etc.).

Very good regulatory knowledge in GMP, Annex 11 (SW validation; part of the EU GMP Guidelines), PIC/S, data integrity (ALCOA+), 21 CFR Part 11 (US counterpart to Annex 11).

Annex 11: "How must IT systems be designed/validated/operated to be GMP-compliant?"

CSV must be the focus "Annex 11 requires validation of computerized systems and CSV is the validation process for it."

Many years of experience with Periodic Reviews and CAPA measures.

General know-how in ensuring that computerized systems comply with regulations (according to PIC/S, Annex 11, 21 CFR Part 11) and are approved by Swissmedic/FDA.

"Enjoys paper - documentation pig" - the person must love documentation, it's 99% of the task.

Periodic Reviews within the scope of Swissmedic inspections.

Documentation/SOPs all in paper form in thick folders, independently navigate through documents, approach colleagues, search proactively.

Absolutely hands-on, not a consultant, not a project manager, but a technical "craftsman" with a lot of initiative, open to routine work and deep dives into SOPs.

Additional Information:

Project No.: 1085339

Job Type: On-site

Start Date: 30.11.2026

Project details

1 year +

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