Senior Validation Engineer
United States, Houston (Texas)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.
Lonza Cell and Gene Therapy Facility is the largest in the world and our facility is growing. We are looking for professionals to grow with us and we have this exciting opportunity in the Quality Assurance Validations group. The Senior Validations engineering position will ensure effective validations execution and maintenance of manufacturing equipment, facilities and process utilities and will also be responsible for the development and the execution of qualifications, validations, re-qualifications and re-validation for process equipment, laboratory equipment, utilities and facilities.
- Generates and executes Validation Project Plans, Validation protocols (IQ/OQ/PQ) and summary reports and SOPs as required LONZA site’s Validation Master Plan, SOPs and global policies. Systems include incubators, BSCs, Autoclaves, Bioreactors, process gases, DI water system, Classified Clean Rooms/HVAC (Grades, A through D), among others.
- Solid knowledge of discipline; able to discuss expectations for validation activities, program and documentation.
- Able to handle some midsize project work but with oversight at a moderate degree.
- Demonstrated ability to plan and organize validation activities amongst cross functional groups; capable of providing and maintaining status updates for validation activities related to day-to-day operations or project work.
- Able to correctly answer questions about day-to-day activities that would be most likely posed by junior level Validation Engineers
- Able to correctly assess change controls with an accurate understanding of the bigger picture implications of changes, that may still need some review and oversight or feedback.
- Bachelor’s degree in life sciences or Engineering required.
- GMP experience in the biologics and pharma industry. Working knowledge of equipment/facilities qualifications, GMP and GDP environment
- Advanced Experience in Validations.
- Thorough knowledge of validation life cycle, validation protocols (IQ/OQ/PQ) generation and execution of manufacturing and laboratory equipment, clean process utilities and classified facilities
- Fundamental understanding of validated computer systems and change management in the commercial pharmaceutical/biotech industry, including training others.
- GMP compliance knowledge including knowledge of 21 CFR Parts 210, 211, 11, GAMP 5 and ISO 13485:2003 requirements, among others
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.