CSV Expert (Pharma)

Responsibilities

Project Number:

1085339

Project Title:

1085339 CSV Expert (Pharma) (m/f/d)

Job Type:

Freelance

• Hands-on support in carrying out the CSV activities planned according to the VMP (Validation Master Plan) and reviewing/validating 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 Documentations
• User Acceptance Tests (UAT)
• Traceability Matrices
• Validation and Completion Reports
• Not a classic consulting role, but rather a hands-on role driving the CSV process, especially regarding documentation, while ensuring GMP compliance.
• Simply get everything related to computer systems down on paper, meaning every device in operation must be validated according to CSV / the main task is documentation!

Requirements

Additional Information:

SOLCOM is one of the leading technology service providers in the areas of software development, IT, and engineering. For over 20 years, we have been working as partners with globally operating top companies in all industries and are deployed worldwide wherever innovation is decisive.

• Min. 5 years of experience in CSV (Computerized System Validation) in the PHARMA environment, including many years of experience in creating/reviewing/approving CSV documents (SRS, FS, IQ, FT, UAT, risk analyses, traceability, etc.).
• Very good regulatory knowledge in GMP, Annex 11 (Software 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 in handling 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.
• Documents/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.

Project details

Zell (Canton of Lucerne)

30.11.2026

1 year +

• Start: 2026-11-30
• Duration: 12 Monate
• Remote: onsite
• Location: Zell (Kanton Luzern), Deutschland, DE
• Languages: German