Quality Validations Engineer

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Overview

Assure that all products manufactured at IA are designed, manufactured and released according to established procedures and validated processes. Assure that all facilities, utilities and equipment involved in the production of all products manufactured at IA complies with defined standards. Assure the proper implementation of good quality practices in all processes at IA and be able to identify improvement opportunities necessary to contribute to the robustness of the IA Quality System.

Responsibilities

Key Accountabilities

• Review and approval of manufacturing procedures, general procedures or instructions.
• Change Management : evaluate the impact of the proposed changes, approve action plan proposal and its implementation.
• Validation / Qualification :

Review of qualifications for facilities, equipment and utilities, including qualification strategy, execution and management of potential deviations detected.

Internal Networking

Qualifications

Minimum Knowledge & Experience required for the position

Required : Bachelor's degree (Licenciatura) in any related area Biotechnology, other Sciences, or related field.

Valuable : Any additional degree higher than that required previously.

Degree may be substituted by relevant skills and work experience.

Years of experience

Minimum of 3 years in a similar position.

Min knowledge

Software : Fluency in Office Tools (Excel & Word), Valuable Basic knowledge in SAP.

Language : Fluency in Spanish or Catalan. Advanced knowledge of English (reading and speaking).

Standards : Knowledge of Quality standards.

Skills & Capabilities

Travel Requirements

Not Required

What we offer

If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.

Werfen appreciates and values diversity. We are an Equal Opportunity / Affirmative Action Employer M / F / D / V.

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