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Senior cleanroom operations manager

Mainz
beBeeCleanroom
Manager
Inserat online seit: 19 Dezember
Beschreibung

At SCHOTT, we're seeking a dedicated professional to lead our cleanroom operations and processes.


About the Role

This critical position is responsible for ensuring regulatory compliance, contamination control, and continuous improvement in our cleanroom environments. As a key member of our team, you'll play a vital role in maintaining high standards of quality and safety.


Key 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 CCS 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


Requirements

* Masters 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; German is a plus
* Strong communication skills


What We Offer

SCHOTT's commitment to employee development is matched only by our comprehensive benefits package. Our employees enjoy flexible working hours, holistic corporate health management, talent development opportunities, and trust-based work arrangements.

We pride ourselves on a culture of equity, diversity, and inclusion. Motivated and committed employees are the foundation of our company's success.

You can expect interesting tasks, challenging projects, and motivated teams working on topics that shape our future. If you're up for the challenge, please submit your application: Heike Haertling, Human Resources.

Cleanroom Specialist

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