Cleanroom operations specialist

Lead Cleanroom Operations

The ideal candidate will oversee global cleanroom operations and processes across sterile and non-sterile sites, ensuring regulatory compliance, contamination control, and continuous improvement.

* Develop and implement monitoring programs to track and analyze data; identify areas for corrective action
* Collaborate with teams to define and enforce gowning protocols for sterile and non-sterile environments
* Validate cleanroom facilities and equipment while maintaining documentation and ensuring alignment with regulatory standards
* Design, maintain, and optimize cleanrooms in accordance with ISO and GMP regulations
* Implement monitoring programs to analyze data and drive corrective actions
* Identify potential risks, conduct root cause analyses, and develop mitigation strategies to improve outcomes
* Master's degree in a relevant field such as microbiology, biotechnology, or engineering
* Minimum 5 years of experience in cleanroom management and/or environmental monitoring within the pharmaceutical industry
* Proven expertise in GMP-compliant process design/management, ISO standards, GMP regulations, and regulatory requirements