Cleanroom Operations Specialist

Expert Contamination Control ProfessionalWe are seeking a dedicated expert to lead global cleanroom operations and processes across sterile and non-sterile sites.Your ResponsibilitiesLead 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.Maintain validation of cleanroom facilities and equipment; 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.Provide training on cleanroom practices and foster a culture of continuous improvement.About YouYou should have a 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 as well as knowledge of ISO standards, GMP regulations, and regulatory requirements.Fluency in English is required, German is a plus.Strong communication skills are essential.