Cleanroom Operations Lead
About Us
We are seeking a dedicated Cleanroom Operations Lead to oversee global cleanroom design, maintenance, and optimization in compliance with ISO and GMP standards.
Job Description
* Develop and implement global monitoring programs; analyze data and ensure corrective actions and CCS implementation
* Define and enforce gowning protocols for sterile and non-sterile environments
* Support validation of cleanroom facilities and equipment; maintain documentation and ensure regulatory alignment
* Ensure adherence to FDA, EMA, and other global standards; manage regulatory documentation and updates
Requirements
* Master's degree in microbiology, biotechnology, engineering, or a related field
* At least 5 years of experience in cleanroom management and/or environmental monitoring in the pharmaceutical industry or a related field
* Experience in GMP-compliant process design/Management as well as knowledge of ISO standards, GMP regulations, and regulatory requirements
* Fluency in English
Benefits
We offer a range of benefits to support your professional growth and well-being, including flexible working hours, hybrid work arrangements, and corporate pension plans.