QA Validation Engineer — Shape GMP Validation Strategy

Nalys; Wallonië; On-site; EUR 55,000 - 75,000; Full time

Job summary

Nalys is seeking a QA Validation Engineer to join the Validation team at a major biopharmaceutical site. You will help define validation strategies and produce documents that frame and close each validation, including Validation Plans and Validation Summary Reports.

You will be the quality voice on equipment, system and process validation, ensuring deliverables are clear, compliant and inspection-ready. Teamwork and precise documentation are essential.

Qualifications

• Experience in validation within GMP pharma/biotech industries.
• Ability to write clear, well-structured compliant validation documents.
• Experience drafting Validation Plans and Validation Summary Reports.
• Hands-on Kneat experience is a plus.
• Fluent in French and proficient in English.
• Strong teamwork and peer-review skills.

Responsibilities

• Define validation strategies for equipment, systems and processes.
• Draft Validation Plans (VP) and Validation Summary Reports (VSR).
• Manage the lifecycle of validation documents in Kneat: authoring, review and approval.
• Ensure all deliverables comply with GMP and corporate quality standards.
• Perform peer reviews of validation documentation within the team.
• Contribute to harmonization of validation practices.

Skills

Pharma/biotech GMP validation

Write clear validation docs

VP & VSR drafting

French & English fluency

Teamwork & peer reviews

Tools

Kneat

Job description

Nalys is seeking a QA Validation Engineer to join the Validation team at a major biopharmaceutical site. You will help define validation strategies and produce documents that frame and close each validation, including Validation Plans and Validation Summary Reports.

You will be the quality voice on equipment, system and process validation, ensuring deliverables are clear, compliant and inspection-ready. Teamwork and precise documentation are essential.