Global Cleanroom Operations Leader
Lead global cleanroom operations and processes, ensuring regulatory compliance, contamination control, and continuous improvement in our clean environments.
Key Responsibilities:
* Design, maintain, and optimize cleanrooms to meet ISO and GMP standards.
* Develop and implement monitoring programs, analyze data, and ensure corrective actions and process implementation.
* Define and enforce gowning protocols for sterile and non-sterile areas.
* Validate cleanroom facilities and equipment, maintaining documentation and ensuring regulatory alignment.
* Ensure adherence to FDA, EMA, and other global standards; manage regulatory documentation.
* Identify risks, conduct root cause analyses, and implement mitigation strategies.
* Provide training on cleanroom practices and foster a culture of continuous improvement.
Requirements:
* Masters degree in microbiology, biotechnology, engineering, or a related field.
* At least 5 years experience in cleanroom management and/or environmental monitoring in the pharmaceutical industry.
* Experience in GMP-compliant process design/management and knowledge of ISO standards, GMP regulations, and regulatory requirements.
* Fluency in English; German is beneficial.
* Strong communication skills.
Why Join Us?
Our company offers a unique corporate culture emphasizing equity, diversity, and inclusion. Enjoy flexible working hours, holistic health management, talent development, and trust-based work arrangements.