Validations Engineer

About the company:

Our client is a global leader in specialized diagnostics, operating directly in more than 30 countries and reaching over 100 territories worldwide through distributors. They develop, manufacture, and distribute integrated diagnostic solutions — including systems, reagents, automation, and software — primarily for hospitals and clinical laboratories.

Driven by innovation, precision, and collaboration, their teams are committed to advancing patient care through excellence in science and technology.

Your Mission

Ensure that all products manufactured by our OEM partners are designed, produced, and released according to established procedures, validated processes, and quality standards. You will also contribute to strengthening Werfen’s Quality System through continuous improvement initiatives.

Main responsibilities

• Review and approve manufacturing procedures and technical changes.
• Evaluate the impact of proposed process/product changes (Change Management).
• Review and execute validations and qualifications (facilities, equipment, utilities, processes, FAT/SAT).
• Perform and approve Risk Assessments.
• Participate in internal and external audits.
• Manage deviations, non-conformities, and CAPAs.
• Provide training in validation and risk management to internal staff.
• Propose and implement improvements to enhance Quality System robustness and best practices.

Requirements:

• Bachelor’s degree in Biotechnology, Life Sciences, or a related field.
• Minimum 3 years of experience in a validation role within the pharmaceutical, biotech, or similar industry.
• Strong knowledge of quality and validation standards.
• Proficiency in MS Office (Excel, Word); basic SAP knowledge is a plus.
• Advanced English (spoken and written); fluent in Spanish or Catalan.
• Methodical, organized, detail-oriented, with strong teamwork and time management skills.

What we offer:

• Join a young and collaborative team in an international environment.
• Hybrid work model: 3 days onsite + 2 days remote.
• Competitive benefits package: health insurance, pension plan, on-site cafeteria, parking, and professional development programs.
• A chance to grow within a global, innovative company driving diagnostic excellence.

If you’re passionate about Quality, Validation, and continuous improvement, we’d love to hear from you!

Apply now or get in touch to learn more about this opportunity.