Looking to speak with experienced CQV Engineers to plan, prepare, and execute commissioning and qualification activities for clean utilities and equipment at a sterile drug-product manufacturing site. Ensure all work aligns with site standards, global procedures, and regulatory expectations.
Key Responsibilities
* Develop and execute CQV documentation and testing for clean utilities and GMP equipment, ensuring compliance with site standards and EU/FDA requirements.
* Drive delivery of CQV scope—safely, on schedule, and with high-quality documentation, including deviation and risk management.
* Conduct FATs and integrate results into the full qualification lifecycle.
* Ensure all required training and project records are completed on time.
Core Competencies
* Proven end-to-end CQV experience across the full project lifecycle.
* Strong background with sterile manufacturing utilities, including PW/WFI, clean steam, and high-purity gas systems.
* Effective communicator with strong documentation, planning, and cross-functional teamwork skills.
* Experience using electronic validation systems (e.g., ValGenesis, Kneat).