The Head of Sterility Assurance is responsible for developing and implementing proactive Sterility Assurance programs for Lonza Houston. Key responsibilities:Developing, implementing and continuously improving biological (viral, bacterial, fungal, mycoplasma, and other adventitious agents) contamination control strategies for sterile manufacturing and manage the sterility assurance team. Driving and overseeing site sterility assurance strategy, risk assessment, mitigation definition and gap clos... more details
Today, Lonza is a global leader in life sciences operating across three 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.
The Head of Sterility Assurance is responsible for developing and implementing proactive Sterility Assurance programs for Lonza Houston.
Key responsibilities:
Developing, implementing and continuously improving biological (viral, bacterial, fungal, mycoplasma, and other adventitious agents) contamination control strategies for sterile manufacturing and manage the sterility assurance team.
Driving and overseeing site sterility assurance strategy, risk assessment, mitigation definition and gap closure and sustainable implementation
Responsible to respond to adverse trends or contamination events with root cause analysis and implementation of preventive actions where appropriate
Supporting coaching and training of employees in all department to improve understanding of biological risks and aseptic practices
Improve procedures for microbiological and segregation control aspects of facility and equipment design, process design, material transfer, maintenance, training, sampling, testing, and cleaning / disinfection
Expert to implement phase appropriate sterility assurance practices as part of the new product introduction process
Supporting microbiological control and sterility assurance across the site.
Key requirements:
Bachelor / Master Degree or Ph.D. in relevant field (natural sciences, Pharmacy, preferred Microbiology)
??Highly experienced within aseptic / sterile manufacturing and Quality Assurance in the pharmaceutical industry
Excellent working knowledge of cGMP and the regulatory requirements for manufacture of sterile and low Bioburden products (FDA, EMA, PIC/s)
Fluency in English (spoken and written)
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.
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