Senior Cleanroom Specialist

About the Role

This position leads global cleanroom operations and processes across sterile and non-sterile sites to ensure regulatory compliance, contamination control, and continuous improvement in cleanroom environments.

Your Key Responsibilities

• Develop and implement global cleanroom design, maintenance, and optimization strategies in compliance with ISO and GMP standards
• Design monitoring programs; analyze data and ensure corrective actions are taken
• Define gowning protocols for sterile and non-sterile environments to minimize contamination risks
• Maintain validation of cleanroom facilities and equipment; document all findings
• Evaluate adherence to FDA, EMA, and other global standards to maintain quality
• Analyze and mitigate risks in cleanroom environments through root cause analyses and implementation of mitigation strategies

Your Profile

• Bachelor's degree or higher in microbiology, biotechnology, engineering, or a related field
• At least 5 years experience in cleanroom management and/or environmental monitoring
• Expertise in GMP-compliant process design/management and knowledge of ISO standards, GMP regulations
• Fluency in English; German is a plus