Validation Analyst - EMA

GxP Validation Analyst – EMA

Brussels- Belgium (Onsite)

Start Date: 1 November

We are looking for an experienced GxP Validation Analyst to join a high-profile Global Instrument Software Validation Project in Brussels. This initiative involves validating over 200 unique laboratory instruments, ensuring compliance with EMA guidelines and aligning instrument software management with internal IT SOPs.

The Role:

• Gather and document requirements (URS, software configuration).
• Develop and execute validation test cases (IQ, OQ, PQ as applicable).
• Prepare requirements specifications, infrastructure diagrams, and data flow diagrams.
• Perform risk assessments and ensure traceability of requirements → risks → tests → results.
• Support SOP migration and alignment with IT practices.
• Collaborate with laboratory, IT, QA, and vendor teams to ensure successful validation.

What you will bring:

• Strong technical writing and documentation skills.
• Proven experience in software validation for lab instruments or GxP-regulated systems.
• Knowledge of EMA guidelines, Annex 11, and GAMP 4.
• Ability to design infrastructure and data flow diagrams.
• Excellent communication and stakeholder management skills.
• Degree in Life Sciences, Computer Science, or Engineering.
• 6–9 years of relevant validation experience in pharma, biotech, or CRO environments.
• Familiarity with CSA (Computer Software Assurance) principles is a plus.

This is an exciting opportunity to contribute to a global validation initiative, ensuring compliance and driving excellence in laboratory software systems.

Hurry and apply for a more detailed conversation with our team!

#UST

Key Skills: GxP | Software Validation | Pharma | Annex 11 | GAMP 4 | Documentation