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CQV Engineer- Equipment Validation

Azzur Group

Irvine, california


Job Details

Temporary


Full Job 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.

Requirements

Qualifications 

  • BS in Engineering, Science or equivalent technical degree.
  • Solid understanding of GMP regulations and industry standards.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and collaboratively in a dynamic team environment.
  • Experience in commissioning, qualification, and validation within the pharmaceutical and/or medical device industry commensurate with the level of the project demand.
  • Experience with qualified complex process equipment like bioreactors, fillers, or centrifuges etc
  • Strong analytical and problem-solving skills with attention to detail.

Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

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