We are recruiting a Clinical CSV Engineer to join a leading Pharmaceutical company in the Walloon Region, Belgium. As the Clinical CSV Engineer will play a critical role in maintaining high standards of system lifecycle management and validation for clinical data systems, working closely with multidisciplinary teams to support clinical study data analysis.
This is a fully remote mission and candidates working from Europe (Except the UK and Germany) can be considered. This is a mission until the end of December 2026, with likely extension to April 2027.
KEY DUTIES AND RESPONSIBILITIE
Your duties as the Clinical CSV Engineer will be varied however the key duties and responsibilities are as follows:
* As the Clinical CSV Engineer, you will perform and coordinate validation activities for GxP clinical and regulatory systems, including writing validation documentation such as URS, risk assessments, IQ/OQ/PQ protocols, and validation reports.
* As the Clinical CSV Engineer, you will manage the full CSV lifecycle, from gathering user requirements to delivering completed validation summaries.
* As the Clinical CSV Engineer, you will support change requests, periodic reviews, and updates across multiple validated systems to ensure continued compliance.
* As the Clinical CSV Engineer, you will collaborate closely with QA, IT teams, and business SMEs to capture clinical workflows and translate them into validation deliverables.
* As the Clinical CSV Engineer, you will engage with stakeholders to align requirements and ensure compliance expectations are met.
* As the Clinical CSV Engineer, you will coordinate validation activities for systems such as Domino, R, SAS, Veeva, or Certara, depending on project roadmaps.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the Clinical Data Integrity & System Validation SME we are looking to identify the following on your profile and past history:
* A Degree or higher level in a relevant field (e.g., Life Sciences, Computer Science, Quality Assurance, or related).
* Proven experience in GxP validation, specifically for clinical or regulatory IT systems.
* Demonstrated ability to manage the entire CSV lifecycle independently, from initial requirements to final validation documentation.
* Strong communication skills, capable of interacting directly with stakeholders with minimal supervision.
* Fluency in English.
Key Words: Clinical / Data / Validation / GxP / CSV / Clinical Systems / Lifecycle / Stakeholders / Compliance / Regulatory / CSV Consultant / CSV Specialist / Computer Systems Validation
\"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.\"