Validation Engineer

Consulting Austin, Texas College Station, Texas


Description

Essential Duties and Responsibilities 

Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. As a CQV Engineer at Azzur Group, you will play a crucial role in ensuring the successful commissioning, qualification, and validation of processes, systems, and equipment for our clients in the Life Sciences sector. We are seeking candidates at various experience levels to support our growing pipeline of projects. Whether you are a seasoned professional or just starting your career in CQV, we welcome diversity in experience and expertise. The following is a short list of the typical responsibilities and deliverables of any given project. 

  • Develop and execute commissioning, qualification, and/or validation protocols for equipment, utilities, and/or facilities in accordance with industry regulations and client specifications.
  • Contribute to the development and revision of Standard Operating Procedures (SOPs) related to CQV processes and ensure that SOPs are in compliance with regulatory requirements and industry best practices.
  • Work collaboratively with project teams to integrate CQV activities seamlessly into project timelines.
  • Provide regular updates through technical presentations on the status of validation activities to project teams and stakeholders.
  • Uphold high standards of quality in project execution, ensuring compliance with GMP (Good Manufacturing Practices) and regulatory guidelines.
  • Identify and assess risks associated with CQV activities and develop mitigation strategies.

Qualifications 

  • Required Education: Bachelor’s degree in Bioengineering, Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or Science related field
    Preferred Education: Bachelor’s or master’s degree in Bioengineering, Biomedical Engineering, Mechanical
    Engineering, Chemical Engineering, or Science related technical degree preferred.
  • 3-5 years’ experience of validation and/or quality in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
  • Knowledge in the areas of validation lifecycle documentation (URS, System Classification, Risk
    Assessment, Design Reviews), and Validation Protocols (IQ, OQ, PQ, PV, CSV,
    requalification/periodic reviews) etc.
  • Preferred experience:
    • 3-5 years project experience with authoring and executing validation protocols of manufacturing process equipment and QC lab equipment, automation/computerized systems, and/or utilities and facilities

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