Validation Engineer: CSV & Regulatory Compliance Expert

ELMEA Consulting Group; Brussel Hoofdstad; Hybrid; EUR 55,000 - 75,000; Full time

Job summary

ELMEA Consulting Group seeks a Validation Engineer to plan, execute, and review IQ/OQ/PQ protocols for equipment, utilities, and facilities. You will perform CSV tasks aligned with GAMP 5 and author comprehensive validation documents.

In this role, you will collaborate with QA, IT, production and engineering, manage deviations and CAPAs, and support regulatory inspections. Fluent English is required; French/Dutch are a plus.

Qualifications

• Engineering or science degree required.
• Minimum 3 years of validation experience in a GMP-regulated environment.
• Strong knowledge of GAMP 5, FDA 21 CFR Part 11, and EU Annex 11.
• Experience with CSV and/or process validation is a strong asset.
• Rigorous, structured, and detail-oriented approach to documentation.
• Fluent in English; French and/or Dutch is a plus.

Responsibilities

• Plan, execute, and review qualification protocols (IQ, OQ, PQ) for equipment, utilities, and facilities.
• Perform Computer System Validation (CSV) activities in line with GAMP 5 guidelines.
• Author and review validation documentation: VMP, URS, FS, DS, test protocols, and final reports.
• Collaborate with cross-functional teams including QA, IT, production, and engineering.
• Manage deviations and CAPAs related to validation activities.
• Support regulatory inspections and internal audits from a validation perspective.
• Ensure compliance with applicable regulations (FDA 21 CFR Part 11, Annex 11, EU GMP).

Skills

GAMP 5

FDA Part 11

EU Annex 11

Process Validation

Documentation

Education

Engineering or science degree

Tools

CSV

Job description

ELMEA Consulting Group seeks a Validation Engineer to plan, execute, and review IQ/OQ/PQ protocols for equipment, utilities, and facilities. You will perform CSV tasks aligned with GAMP 5 and author comprehensive validation documents.

In this role, you will collaborate with QA, IT, production and engineering, manage deviations and CAPAs, and support regulatory inspections. Fluent English is required; French/Dutch are a plus.