Job Title:
Expert Contamination Control
About this Role:
We are seeking a dedicated Cleanroom Specialist to lead global cleanroom operations and processes. This critical role ensures regulatory compliance, contamination control, and continuous improvement in our cleanroom environments.
Your Key Responsibilities:
* Lead the design, maintenance, and optimization of cleanrooms in compliance with ISO and GMP standards.
* Develop and implement global monitoring programs; analyze data and ensure corrective actions and implementation of best practices.
* 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.
* Provide training on cleanroom practices and foster a culture of continuous improvement.
About You:
* A Master's degree in microbiology, biotechnology, engineering, or a related field is required.
* At least 5 years of experience in cleanroom management and/or environmental monitoring in the pharmaceutical industry or a related field is necessary.
* Experience in GMP-compliant process design/management as well as knowledge of ISO standards, GMP regulations, and regulatory requirements is essential.
* Fluency in English is required; German is a plus.
* Strong communication skills are necessary.