Expert Contamination Control / Cleanroom Expert (m/w/d)*

Expert Contamination Control / Cleanroom Expert (m/w/d)

SCHOTT Mainz, Rhineland-Palatinate, Germany.

We are looking for a dedicated Expert Contamination Control / Cleanroom Expert to lead global cleanroom operations and processes across our sterile and non-sterile sites. This role is critical to ensuring regulatory compliance, contamination control, and continuous improvement in our cleanroom environments.

Responsibilities

• Lead global cleanroom design, maintenance, and optimization in compliance with ISO and GMP (EU Annex I) standards.
• Develop and implement global monitoring programs; analyze data and ensure corrective actions and corrective and preventive actions (CAPA) implementation.
• 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.

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.

Benefits

In addition to a competitive salary, SCHOTT offers flexible working hours, hybrid work options, holistic corporate health management, talent development, and a trust‑based working time arrangement. SCHOTT values equity, diversity, and inclusion and encourages all employees to develop their full potential.

Contact

Please send your application to SCHOTT Pharma AG & Co. KGaA, Human Resources, Heike Haertling. *At SCHOTT, it’s your personality that counts – not your gender, your identity, or origin.