QA Validation Lead
United States, Hayward (California)
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.
QA Validation Lead
This position supports the validation/engineering team for the facility by providing Quality oversight of qualification and/or validation activities for equipment, and manufacturing processes. Activities include review of validation protocols, data and reports. Collaborates with validation/engineering on change controls, validation approaches, equipment issues, etc. Participates on risk assessments for new equipment and process changes
- Applies thorough understanding of cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
- Provides Quality oversight on a variety of projects in areas that may include process qualification, sterilization, cleaning and equipment Validation, as well as projects/studies to support manufacturing.
- Handles projects that are more complex and broad in scope, such projects require leadership, task prioritization, and management of time constraints. Must demonstrate competent and effective planning, coordination, collaboration and organizational skills.
- Reviews protocols, reports, Change Controls, and validation data. Provide Quality guidance in validation approach. Provide assessment on impact of equipment and process changes.
- Provides mentoring and leadership to less experienced staff.
- Handles routine tasks timely, accurately.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievement 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.