Validation Specialist

3 weeks ago


Los Angeles, California, United States Azzur Group Full time

As a key member of the Azzur Group team, you will play a vital 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 with a strong background in commissioning, qualification, and validation 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 are 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.
  • Crafting commissioning and qualification protocols, conducting rigorous testing, and documenting the compliance of all systems to meet your specific requirements.
  • Generate, revise, manage, and execute the document set (VPP, MVP, URS, SIA, FS/DS, Commissioning Protocol, Final Report, IOQ, PQ, Traceability Matrix) for each equipment as applicable, throughout its lifecycle.

Facilities and utilities include:

  • HVAC, Building Automation System (BAS), Environmental Monitoring System (EMS), CO2, Controlled Compressed Air (CCA), Liquid Nitrogen (LN2), Power, Emergency Power

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.

BS in Engineering, Science or equivalent technical degree.

Strong technical writing is key.

Building automation system and environmental monitoring system qualification.

Experience in commissioning, qualification, and validation within the pharmaceutical and/or medical device industry commensurate with the level of the project demand.



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