Job Opportunity
We are seeking a skilled professional to lead global cleanroom operations and processes across sterile and non-sterile sites. This role is critical to ensuring regulatory compliance, contamination control, and continuous improvement in cleanroom environments.
Key Responsibilities
* Lead global cleanroom design, maintenance, and optimization in compliance with ISO and GMP standards
* 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
* Identify risks, conduct root cause analyses, and implement mitigation and improvement strategies
Requirements
* Masters 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; German is a plus
* Strong communication skills
Benefits
Our organization offers a range of benefits to support your career development and work-life balance. These include active health management, flexible working hours, hybrid work options, and corporate pension plans.
We value equity, diversity, and inclusion in our workplace and provide opportunities for motivated employees to develop their potential.