CSV Engineer – Life Sciences Validation Specialist

EFOR (formerly CVO-Europe); Wallonië; Sur place; EUR 55 000 - 85 000; Plein temps

Résumé du poste

EFOR is seeking a CSV Engineer in Belgium to validate and maintain computerized systems in a GMP/GxP environment. You will define validation strategies and manage documentation across the lifecycle.

You will collaborate with Quality, IT, Engineering and Production teams to ensure continued validated status, data integrity, and adherence to 21 CFR Part 11 and EU Annex 11 where applicable.

Qualifications

• Degree in Engineering, IT, Life Sciences or Pharmacy.
• Experience in Computerized System Validation (CSV) in regulated environments.
• Knowledge of GMP/GxP requirements and Data Integrity.

Responsabilités

• Defining and implementing Computerized System Validation strategies.
• Preparing, reviewing and executing validation documentation (URS, Risk Assessments, Validation Plans, IQ, OQ, PQ, Validation Reports).
• Performing GxP and system impact assessments.
• Defining and executing risk-based validation approaches.
• Reviewing and approving test protocols, results and validation evidence.
• Managing deviations, discrepancies and CAPAs related to validation activities.
• Assessing system changes and ensuring continued validated status through change control.
• Supporting Data Integrity and compliance assessments.
• Ensuring GMP/GxP compliance and industry standards.
• Collaborating with Quality, IT, Automation, Engineering, Production, system owners and suppliers.
• Supporting computerized systems lifecycle from implementation to operation and retirement.

Connaissances

Engineering

IT

Computerized System Validation

GMP/GxP

Data Integrity

GAMP 5

21 CFR Part 11

Teamwork

Formation

Engineering degree (Life Sciences, IT, or equivalent)

Pharmacy or Life Sciences background

Outils

URS

IQ/OQ/PQ

Description du poste

EFOR is seeking a CSV Engineer in Belgium to validate and maintain computerized systems in a GMP/GxP environment. You will define validation strategies and manage documentation across the lifecycle.

You will collaborate with Quality, IT, Engineering and Production teams to ensure continued validated status, data integrity, and adherence to 21 CFR Part 11 and EU Annex 11 where applicable.