Validations Engineer

About the client:

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

At Werfen we are driven by innovation precision and collaboration. Our people are at the heart of everything we do 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 Werfens 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:

• Bachelors 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 youre passionate about Quality Validation and continuous improvement wed love to hear from you!

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