Job Description
We are seeking a dedicated Cleanroom Operations Expert to lead global cleanroom processes across sterile and non-sterile sites.
* Develop and implement global monitoring programs; analyze data and ensure corrective actions and compliance with industry standards
* Define and enforce gowning protocols for sterile environments, ensuring regulatory alignment and equipment validation
* Support the implementation of continuous improvement strategies in cleanroom facilities and management
* Ensure adherence to FDA, EMA, and other global regulations; manage documentation and updates
* Identify risks, conduct root cause analyses, and implement mitigation strategies
* Provide training on cleanroom best practices and foster a culture of continuous improvement
About the Role
* 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
* Experience in process design/Management as well as knowledge of ISO standards, GMP regulations, and regulatory requirements
* Fluency in English; German language skills are a plus
* Strong communication skills
Key Responsibilities:
* Develop and maintain global cleanroom operations and procedures
* Implement and maintain quality control systems
* Collaborate with cross-functional teams to ensure regulatory compliance
* Provide expert advice on cleanroom design and maintenance
Required Skills:
* Excellent analytical and problem-solving skills
* Ability to work in a fast-paced environment
* Strong attention to detail and organizational skills
What We Offer:
* A competitive salary and benefits package
* Opportunities for professional growth and development
* A dynamic and supportive work environment