CQV Engineer Role Summary
Our organization seeks a seasoned Commissioning, Qualification, and Validation (CQV) professional with a proven track record in delivering CQV services across GMP-regulated facilities. We require an experienced CQV Engineer to develop and execute comprehensive CQV documentation.
Key Responsibilities:
* Develop comprehensive CQV documentation for URS, DQ, FAT/SAT, IQ, OQ, and PQ activities.
* Lead the commissioning of equipment and systems ensuring proper installation, utility integration, control functionality, and safety features.
* Collaborate with vendors, automation, engineering, and quality teams to coordinate execution and resolve issues.
Requirements:
* Bachelor's degree in Engineering, Life Sciences, or a related field.
* Minimum 5 years of CQV experience in drug substance or biologics manufacturing under GMP.
* Hands-on experience with commissioning and qualification of large-scale bioprocess equipment, utility systems, and automation-integrated systems.