Agenus

Validation Engineer

US-MA-Lexington
Job ID
2017-1333
Category
Quality

Overview

The Validation Engineer is responsible for working closely with functional areas to develop, execute and summarize validation documentation for GMP equipment, systems, processes, and facilities.  The candidate who fills this role is responsbile for all new and existing equipment, systems, processes, and facilities at the Lexington location.

Responsibilities

  • Develop validation master plans, process flow diagrams, protocols, or standard operating procedures.
  • Prepare qualification designs to include sampling, testing, or analytical methodologies.
  • Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical, electronics, or other types of production.
  • Identify deviations from established standards and provide recommendations for resolving deviations.
  • Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
  • Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems
  • Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
  • Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.
  • Prepare detailed reports based on results of validation and qualification tests or reviews of procedures and protocols.
  • Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or novel technologies.
  • Prepare, maintain, or review validation and compliance documentation, such as engineering change notices, schematics, or protocols.
  • Assist in training equipment operators or other staff on validation protocols and standard operating procedures.
  • Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.
  • Communicate with regulatory agencies regarding compliance documentation or validation results.

Maintain validation test equipment

Qualifications

  • Bachelors Degree in Engineering or related science field.  Ten years experience in the pharmaceutical or biopharmaceutical industry with 5+ years of hands-on experience.

 

Extensive knowledge of validation requirements for US and EU compliance regulations and industry practices

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