Back to Job SearchAn exciting opportunity for a CSV & Data Integrity Expert to join a leading pharmaceutical company, working within an innovative Gene Therapy project. This senior role is based in a GMP-regulated environment, where your expertise will be pivotal in leading Data Integrity and Computer System Validation activities across multiple project streams, including utilities, drug substance, drug product, and analytical laboratories.
The position involves acting as a Subject Matter Expert, providing leadership and strategic direction throughout the project lifecycle. The role requires close collaboration with cross-functional teams to ensure compliance with regulatory standards and support validation, risk assessments, and audit readiness.
This is an initial mission until end of 2026, with likely extension to end of 2027. The mission requires a minimum of 3-4 days per week onsite in the Walloon Region, Belgium.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the CSV & Data Integrity Expert will be varied however the key duties and responsibilities are as follows:
- Lead Data Integrity and CSV activities, ensuring compliance with GMP standards and regulations throughout the project lifecycle.
- Drive Data Integrity Risk Assessments (DIRA), gap analyses, and validation of GMP systems such as EMS, BMS, PCS/DCS, and SCADA.
- Review and approve audit trails, electronic records, signatures, system security, access controls, and disaster recovery processes.
- Coordinate with IT, quality, and project stakeholders to implement and test automation validated systems.
- As the CSV & Data Integrity Expert, you will manage stakeholder engagement, drive deliverables, and ensure activities meet regulatory and internal standards.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the CSV & Data Integrity Expert we are looking to identify the following on your profile and past history:
- A Degree or higher level in Engineering, Pharmaceutical Sciences, Quality Assurance, or related field.
- Proven experience with Data Integrity principles, risk-based CSV approaches, and executing Data Integrity Risk Assessments (DIRA).
- Extensive experience in CSV commissioning and qualification activities within GMP-regulated environments.
- Strong pharmaceutical or biotechnology industry background, with hands-on experience reviewing audit trails, electronic records, signatures, and audit readiness.
- As the CSV & Data Integrity Expert, you will demonstrate excellent stakeholder leadership, communication skills, and a proactive mindset.
Key Words: CSV / Data Integrity / Validation / GMP / 21 CFR Part 11 / Risk Assessments / Pharmaceuticals / Biotechnology / GAMP 5 / Regulatory Compliance / Automation Systems / Audit Readiness / Cross-functional Collaboration / Pharma / Biotech / CGT / C> / Gene Therapy / Gene Therapies / CSV / Computer Systems Validation / CSV / Data Integrity / DI
"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."
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.
