Validations Engineer

Job Summary

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Assure that all products manufactured at OEM 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 OEM complies with defined standards. Assure the proper implementation of good quality practices in all processes at OEM and be able to identify improvement opportunities necessary to contribute to the robustness of the OEM Quality System.

Key Accountabilities

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• 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:
  
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  • Review of qualifications for facilities, equipment and utilities, including qualification strategy, execution and management of potential deviations detected.
    
  • Factory acceptance Test (FAT) / Site acceptance test (SAT) execution / approval.
    
  • Review of process validations, including validation strategy, execution and management of potential deviations detected.
    
  • Be able to establish a strategy to validate changes. Review validation strategies and the corresponding documentation (protocol and report).
    
  
  
  
• Risk Assessment:
  
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  • Carry out, review and approve the risk assessment performed at OEM to evaluate the impact of changes in the final product.
    
  
  
  
• Provide training in validation & risk management to OEM staff to ensure that the organisation is both skilled in implementation and is utilising best in class methodologies.
  
• Participate in Internal and External Audits as needed.
  
• Perform Quality Training to all personnel at OEM.
  
• Management of Non-conformances and CAPA.
  
• Ensure that validation lots are appropriately tested, reviewed and released.
  
• Implement new procedures and instructions as a result of the observed practices on site to contribute to the Quality System robustness.
  
• Be proactive regarding the continuous improvement in Quality processes and procedures.
  

Networking/Key relationships

To be determined based on department needs, to include interactions such as:

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• Operations Area
  
• R&D Area
  

Minimum Knowledge & Experience required for the position

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• Education:
  
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  • Required: Bachelor's degree (Licenciatura) in any related area Biotechnology, other Sciences, or related field.
    
  • Degree may be substituted by relevant skills and work experience.
    
  • Valuable: Any additional degree higher than that required previously.
    
  
  
  
• Experience: Minimum of 3 years in a similar position.
  
• Additional Skills/Knowledge:
  
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  • 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
    
  
  
  

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirements.

Skills & Capabilities

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• Management of decisions under pressure.
  
• Methodical and well-organized person.
  
• Teamwork.
  
• Time management skills.
  
• Ability to express information clearly and concisely to the staff, ensuring their understanding.
  
• Ability to apply a systematic approach and constant control, follow-up and verification of the results.
  
• Ability to collaborate, participate and coordinate actively with working group.
  
• Reflects values of Werfen in the quality of work and working relationship. xqbhyrx
  

Travel requirements

Not required.

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