Global Sterility Assurance Microbial Control Lead

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Lead the Global Sterility Assurance Microbial Control team in Houston, TX. Ensure zero contaminations across all CGT sites.

Key responsibilities:

• Develop and implement an effective sterility assurance program across all CGT sites.

• Act as Global Operations oversight for Sterility Assurance improvement projects within the CGT network.

• Support and coordinate a network of Sterility Assurance SMEs and specialists to build and share standard methodologies.

• Ensure Process Development activities align with cGMP expectations.

• Maintain and update aseptic education and awareness-training programs in collaboration with Site and Global collaborators.

• Provide sterility assurance expertise on facility designs, flows, zone concepts, investigations, and new product introductions.

• Regularly review and align standard methodologies to achieve the vision zero goal, including Aseptic behavior, Sterilization, APS, Material controls, Clean room management, and Supplier management.

• Provide on-site support for preventive and corrective actions resulting from critical investigations, audits, and inspection findings.

• Work with global and site QC microbiology on sterility assurance topics, including sterility test failures and EM excursions.

• Perform and review Contamination Risk Assessments to harmonize standards across sites.

• Develop, implement, and improve sterility assurance guidelines and concepts in line with current regulations and industry standards.

• Ensure clear communication between CGT sites for sharing events and lessons learned.

• Mentor Operations, junior team members, and Site Sterility Assurance Points of Contact.

Key requirements:

• Proven experience in sterility assurance and contamination control within the CGT or pharmaceutical industry.

• Strong understanding of cGMP expectations and regulatory requirements.

• Outstanding ability to lead and mentor a diverse team.

• Strong communication skills to coordinate with Global and Site collaborators.

• Demonstrated expertise in facility design and process lifecycle management.

• Ability to successfully implement and maintain sterility assurance programs.

• Experience with conducting and articulating Contamination Risk Assessments.

• Dedication to continuous improvement in sterility assurance practices.

• Bachelor's degree in science related field.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.