Azzur Group Careers

Description

As a Commissioning Qualification Validation Engineer (CQV), you will play a pivotal role in ensuring the successful commissioning, qualification, and validation of critical systems.  Your expertise will be integral in qualifying systems such as Autoclaves, Glassware Washers, Clean Compressed Air, Clean Steam, Clean-in-Place (CIP), Water for Injection (WFI), Heating, Ventilation, and Air Conditioning (HVAC), and Plant Steam systems. In addition to Facility and Manufacturing equipment, a background in qualifying and validating Lab Equipment is essential for a CQV Engineer.

Commissioning: Lead or support commissioning activities for cleanroom systems and
equipment, ensuring proper installation and functionality according to design
specifications.
Qualification and Validation: Develop and execute qualification and validation
protocols for QC Lab Equipment (examples are HPLC, CTUs, Balances, BacT Alert,
ViCell Blu), cleanroom systems including autoclaves, glassware washers, and clean
utilities such as compressed air, steam, and water systems.
Documentation and Reporting: Maintain comprehensive documentation of
commissioning, qualification, and validation activities. Generate protocols, execute tests,
and prepare final reports ensuring compliance with regulatory requirements and company
standards.
Troubleshooting and Optimization: Identify and resolve technical issues during
commissioning and validation activities. Optimize system performance through
troubleshooting, root cause analysis, and process improvements.
Compliance Assurance: Ensure all commissioning and validation activities adhere to
regulatory requirements such as FDA, cGMP, and ISO standards. Stay abreast of
regulatory updates and industry best practices to maintain compliance.

Requirements: 

• Bachelor’s degree in Engineering, Life Sciences, or related field. Advanced degree
  preferred.
• Proven experience in commissioning, qualification, and validation of QC Lab Equipment,
  cleanroom systems and equipment, in a biopharmaceutical or biotechnology
  environment.
• Strong understanding of regulatory requirements and guidelines including FDA, cGMP,
  ALCOA+, and ISO standards.
• Proficiency in developing and executing validation protocols, and protocols and
  documenting validation activities in a regulated environment and creating
  final protocol packages and final reports.
• Required technical expertise in QC Lab environments, cleanroom systems including
  autoclaves, glassware washers, clean utilities (compressed air, steam, water), HVAC, and
  steam systems.
• Analytical mindset with excellent problem-solving skills and attention to detail.
• Effective communication and interpersonal skills, with the ability to collaborate across