Cleaning Validation Engineer — Regulatory Excellence & Impact

Elmea Consulting; Brussel Hoofdstad; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

Elmea Consulting is seeking a highly motivated Cleaning Validation Engineer to join our regulated pharmaceutical team. You will work with site teams to develop, improve and harmonise Cleaning Validation practices globally.

The role focuses on regulatory compliance, patient safety and continuous improvement, combining hands-on validation work with proactive collaboration across Quality, Manufacturing and Engineering.

Qualifications

• Proven experience in Cleaning Validation within pharmaceutical, biotech or other highly regulated industry
• Strong knowledge of GMP requirements and Cleaning Validation regulations

Responsabilités

• Develop and harmonise Cleaning Validation practices across units
• Define cleaning strategies, MACO/HBEL/PDE criteria
• Prepare and review Cleaning Validation protocols and reports
• Ensure GMP compliance and regulatory readiness
• Support deviations, investigations and CAPA
• Coach colleagues on technical cleaning validation concepts

Connaissances

Cleaning Validation

GMP knowledge

QA/Regulatory

Risk management

Cross-functional collaboration

Data integrity

CAPA investigations

Analytical thinking

Description du poste

Elmea Consulting is seeking a highly motivated Cleaning Validation Engineer to join our regulated pharmaceutical team. You will work with site teams to develop, improve and harmonise Cleaning Validation practices globally.

The role focuses on regulatory compliance, patient safety and continuous improvement, combining hands-on validation work with proactive collaboration across Quality, Manufacturing and Engineering.