What are the responsibilities and job description for the VALIDATION ENGINEER position at Azzur Group?
Azzur Group is a GxP compliance and consulting organization focused on providing quality-driven solutions that propel life science companies toward success. If you're a dedicated professional with a desire to engage, learn, and adapt within a dynamic healthcare landscape, you will fit right into our core values : Put Others First, Have the Courage to Take Action, Take Personal Responsibility, and Have Fun!
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.
Salary- Up to $120K
Requirements
- Bachelor's degree in Engineering, Life Sciences, or related field. Advanced degree
preferred.
cleanroom systems and equipment, in a biopharmaceutical or biotechnology
environment.
ALCOA , and ISO standards.
documenting validation activities in a regulated environment and creating
final protocol packages and final reports.
autoclaves, glassware washers, clean utilities (compressed air, steam, water), HVAC, and
steam systems.
Benefits
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.
Salary : $120,000
