Computerised Systems Validation; CSV Expert

Computerised Systems Validation (CSV) Expert

Make an impact in Life Sciences through advanced analytics

Do you have a deep understanding of GAMP5 and FDA regulations? Are you experienced in validating statistical computing environments? Do you want to support leading Pharmaceutical and CRO organisations with their compliance challenges?

Working as a Computerised Systems Validation (CSV) Expert for OCS Consulting, you will be a key contributor to the quality assurance and validation frameworks of our clients and our internal managed services. You will bridge the gap between IT infrastructure and regulatory compliance, ensuring that systems used in clinical research meet the highest standards of integrity and reliability.

In this position, you will lead and execute validation projects for our clients in the Life Sciences sector (Sponsors and CROs). You will be responsible for the full validation lifecycle, ensuring compliance with GxP, FDA 21 CFR Part 11, EU Annex 11, and FDA CSA (Computer Software Assurance). Your specific focus areas will include:

• SAS Software Implementation: You will manage the entire Quality Assurance workflow for the implementation of SAS environments at client sites. This involves defining the validation strategy, writing validation plans, executing protocols, and delivering the final validation summary report.
• R & Posit (RStudio) Implementation: You will apply your validation expertise to open-source environments. A key responsibility is designing and executing the validation process for R packages to create fully validated R environments for clinical analysis.
• internal SOP Development: You will author and maintain Standard Operating Procedures (SOPs) for OCS Consulting’s internal managed services. These SOPs will govern how we deliver system administration, monitoring, upgrades, and change management to our clients, ensuring our own service delivery is compliant and standardised.

We are looking for a professional who combines technical knowledge with a pragmatic approach to quality. We are especially keen to meet people who:

• Have solid experience with GAMP5
  , FDA 21 CFR Part 11
  , EU Annex 11
  , and ICH-GCP
  .
• Are familiar with the emerging FDA CSA (Computer Software Assurance) guidelines.
• Have a background in validating statistical software such as SAS or R (Posit/RStudio).
• Possess strong writing skills for technical and quality documentation (SOPs, Validation Plans, URS, IQ/OQ/PQ).
• Can work independently and communicate effectively with both IT technical teams and Quality Assurance departments.
• Are fluent in English (spoken and written).

OCS Consulting has a long-standing partnership with SAS Institute and is a trusted partner for the Life Science industry. We have been named SAS Solution Provider and Partner of the Year multiple times. This not only shows our strong connection to SAS but also the excellence of our consulting team and the quality of our services, which gives you a head start.

We value long‑term relationships with staff, clients and partners. All our relationships are based on a partnership model of collaboration, trust and mutual respect. Our employees are vital to our success, and we aim to attract the best people who will stay and grow with us.

• Permanent contract (full‑time or part‑time: 32–36 hours per week)
• Competitive salary (€4.000 - €7.000 gross per month, depending on experience)
• 24–28 days’ holiday, with the option to purchase additional days
• International, collaborative work environment (offices in the Netherlands, Belgium, the UK, and Switzerland)

Apply now and grow your career with OCS Consulting. The trusted SAS partner for Life Sciences across Europe.

No agencies please! Acquisition through this vacancy is not appreciated. OCS Consulting accepts no unwanted help from (recruiting) bureaus. CV’s being sent to any employee of OCS Consulting without a specific assignment/contract will be treated as our property and be used as such, for which no payment is due.

Contact us to apply or learn more about the opportunities we offer.