QA Validation Engineer
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QA Validation Engineer – Validation Strategy & Documentation
About Nalys
Nalys is a growing consultancy company specialized in high-tech engineering and life sciences. Founded 15 years ago, we partner with leading organizations to deliver innovative solutions and expert support across a wide range of technical domains.
At Nalys, we believe in combining deep expertise with a human-centric approach — empowering our consultants to thrive and our clients to succeed.
Joining Nalys means becoming part of a collaborative, agile, and forward-thinking team that values excellence, innovation, and continuous growth.
Job Description
As a QA Validation Engineer, you will join the Quality Assurance Validation team of a major biopharmaceutical site.
Your mission will be to help define validation strategies and to produce the documents that frame and close each validation: Validation Plans and Validation Summary Reports.
You will be the quality voice on equipment, system and process validation, working hand in hand with project and quality teams to make sure every deliverable is clear, compliant and inspection-ready.
We’re looking for a rigorous validation professional who writes with precision and enjoys being part of a team that shares and aligns its practices.
The Role & Responsibilities
Working within the QA Validation team and in close collaboration with project and quality stakeholders, your responsibilities will include:
- Defining validation strategies for equipment, systems and processes
- Drafting Validation Plans (VP) and Validation Summary Reports (VSR)
- Managing the lifecycle of validation documents in Kneat: authoring, review and approval
- Ensuring all deliverables comply with GMP requirements and corporate quality standards
- Performing peer reviews of validation documentation within the team
- Contributing to the harmonization of validation practices.
Skills & Qualifications
- You have solid experience in validation within the pharmaceutical or biotech industry, in a GMP environment
- You know how to write clear, well-structured and compliant validation documents
- Experience drafting Validation Plans and Validation Summary Reports is a strong asset
- Hands-on experience with Kneat is a plus
- You are fluent in French and have a professional level of English
- You enjoy teamwork, cross-reviews and sharing best practices.
The Recruitment Process
By applying for the “QA Validation Engineer” position, you will go through the following steps in our recruitment process:
- Olivia Braszko, TA Specialist, will analyze your resume and cover letter and schedule a first screening
- You will have a second interview with our Technical Director, Yves Le Goff, and the TA Specialist
- The last interview will be with our Business Unit Director, Alexandre Ivankovich.
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