Senior CSV & Data Integrity Engineer – GMP, Gene Therapy

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

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.