Validation Engineer

Your Role

Plan, define, and execute Computer System Validation (CSV) activities in compliance with GxP guidelines, including GAMP5, FDA, and EMA requirements.

Develop and maintain validation documentation, including:

• Validation Plans (VP)
• User Requirement Specifications (URS)
• Functional and Design Specifications (FS/DS)
• IQ/OQ/PQ protocols and reports

Your Profile

• Academic background in Pharmaceutical Sciences, Life Sciences, Engineering, or a related field, with an understanding of regulated environments and industry practices.
• Strong experience in Computer System Validation (CSV) within regulated environments such as pharmaceutical or biotech, with solid knowledge of GxP, GAMP5, and compliance standards.
• Proven ability to translate business and regulatory requirements into validation deliverables, ensuring full traceability and high-quality documentation.
• Hands-on expertise in validation lifecycle activities, including URS, FS/DS, and IQ/OQ/PQ, combined with a structured and detail-oriented approach.
• Comfort working in international, multicultural teams, with strong communication skills and fluency in English.

What You'll Love About Working Here

• Multicultural and inclusive team environment.
• Supportive atmosphere promoting work-life balance.
• Hybrid work.
• Career growth programs, training, and certifications in cutting-edge technologies.
• Exciting national and international projects.
• Health and life insurance.
• Referral program with bonuses for talent recommendations.
• Great office locations.