About This Role
We are seeking a seasoned Cleanroom Operations Leader to drive the development and implementation of global cleanroom strategies, ensuring compliance with ISO and GMP standards. Key responsibilities will include designing and maintaining cleanrooms, developing monitoring programs, and analyzing data to inform corrective actions.
Your Key Responsibilities
* Develop and implement global cleanroom design and maintenance strategies in compliance with regulatory requirements.
* Analyze data from monitoring programs and implement corrective actions to maintain high-quality cleanroom environments.
* Define and enforce gowning protocols for sterile and non-sterile environments to prevent contamination.
* Support the validation of cleanroom facilities and equipment, ensuring regulatory alignment.
* Maintain expertise on FDA, EMA, and other global regulatory standards, managing documentation and updates.
* IDentify risks and develop mitigation strategies to minimize disruptions.
* Provide training on cleanroom practices and foster a culture of continuous improvement within the organization.
Your Qualifications
* 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 and knowledge of ISO standards, GMP regulations, and regulatory requirements.
* Fluency in English; German is a plus.
* Strong communication skills and ability to collaborate effectively with cross-functional teams.
About Working With Us
We offer a unique corporate culture that values equity, diversity, and inclusion. Our motivated employees are key to our success, and we provide flexible working hours, holistic health management, talent development, and trust-based working time as part of our benefits package.