Job Title: Lead Cleanroom Operations and Processes
We are seeking a dedicated professional to lead global cleanroom operations and processes across sterile and non-sterile sites.
This role is critical in ensuring regulatory compliance, contamination control, and continuous improvement in our cleanroom environments.
About the Role:
As a Lead Cleanroom Operations and Processes expert, you will be responsible for leading global cleanroom design, maintenance, and optimization in compliance with ISO and GMP standards.
You will develop and implement global monitoring programs, analyze data, and ensure corrective actions and CCS implementation.
You will also define and enforce gowning protocols for sterile and non-sterile environments, support validation of cleanroom facilities and equipment, and maintain documentation and ensure regulatory alignment.
Key Responsibilities:
* Lead 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
* 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
Requirements:
To be successful in this role, you will need:
* 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; German is a plus
* Strong communication skills
What We Offer:
We offer a unique corporate culture where everyone has the opportunity to develop their entire potential.
Our company emphasizes equity, diversity, and inclusion, and we know that motivated and committed employees are the precondition for our success.
Flexible working hours, holistic corporate health management, talent development, and trust-based working time are just a few of the benefits we offer.
How to Apply:
If you are interested in this challenging role, please send us your application.
We look forward to receiving your CV and cover letter.
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