CSV DI Engineer

Hyper Recruitment Solutions Ltd; Waals-Brabant; Sur place; EUR 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Equal Opportunities employer

Résumé du poste

Hyper Recruitment Solutions Ltd in Belgium is seeking a senior CSV & Data Integrity Expert to lead Data Integrity and CSV activities across multiple streams in a GMP-regulated environment. You will act as SME, guiding validation, risk assessments, and audit readiness with cross-functional teams.

The role requires collaboration with IT, quality, and project stakeholders, and supports validation efforts. Initial mission until end of 2026, with extension likely through 2027.

Qualifications

• A Degree or higher in Engineering, Pharmaceutical Sciences, Quality Assurance, or related field.
• Proven Data Integrity principles experience and risk-based CSV approaches.
• Experience with CSV commissioning and qualification in GMP environments.

Responsabilités

• Lead Data Integrity and CSV activities in GMP-regulated projects.
• Drive Data Integrity Risk Assessments (DIRA) and validation.
• Review audit trails, electronic records, signatures, and system security.
• Coordinate with IT and quality teams to validate automation systems.

Connaissances

Data Integrity

CSV

GMP

Audit readiness

Stakeholder management

Formation

Bachelor's degree or higher

Outils

EMS

BMS

PCS/DCS

SCADA

Description du poste

An 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

• 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

• 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.