Lonza
Head of QEF Contamination Control (f/m/d)
Location: Visp, Bend (OR), Nansha. Hybrid.
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.
Responsible for developing and implementing proactive Contamination Control Strategy programs for Lonza’s operations globally.
What you’ll get:
An agile career and dynamic working culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
What you’ll do:
Drive and oversee global Foreign matter contamination control strategy, risk assessment, mitigation definition, gap closure and sustainable implementation in close collaboration with all sites and their quality and operations teams.
Assist assigned sites in response to adverse trends or contamination events with root cause analysis and global implementation of preventive actions where appropriate.
Supports coaching and training of employees at manufacturing sites to improve understanding of foreign matter ingress risks and contamination control best practices.
Approve standardized procedures across the network for foreign matter contamination control aspects of facility and equipment design, process design, material transfer, maintenance, training, sampling, testing, and cleaning.
Responsible Global expert for implementing phase-appropriate contamination control practices as part of the new product introduction process and through interactions with project teams and customers.
What we’re looking for:
Excellent working knowledge of cGMP and the regulatory requirements for manufacture of Pharmaceutical products (FDA, EMA, PIC/s)
Ability to apply contamination control concepts and risk assessment in a practical way, and to coach / teach team members in these areas
Hands-on experience in complex investigations in both preventive and reactive contamination control
Technical knowledge of facility design, clean room engineering, including particle and
Microbial control mechanisms, qualification and maintenance of clean rooms.
Bachelor’s Degree in Life science and Green Belt Certification.
Empathy and resilience. Excellent communication skills at all levels in the organization.
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.