Process Validation Engineer II
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.
Lonza Houston’s 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 an exciting opportunity in the Manufacturing Sciences and Technology (MSAT) department as a Process Validation Engineer. The Process Validation Engineer will be responsible for the design of various qualifications such as: Aseptic Process Simulations, Intermediate Chemical and Sterile Hold Time Studies, Mixing Validations, and Process Performance Qualifications. The Process Validation Engineer will play a critical role, ensuring that both cell and viral vector drug product manufacturing processes are consistent, reliable, and reproducible.
Key responsibilities:
- Develops validation plans, qualification protocols, compiles and analyzes data, drafts summary reports, and reviews validation documentation to ensure products are manufactured in accordance with applicable regulatory agencies, clients and Lonza specifications/requirements.
- Assures that all validation documentation meets or exceeds the regulatory expectations set forth by 21 CFR 210, 211, 212, Part 11, ICH (Q7/8/9/10), EMA, and USP (relevant chapters).
- Represents Process Validation on internal teams (e.g. DRB, CCC, and Daily Management System meetings).
- Able to work with minimal assistance and supervision on process validation discrepancies or investigations. Able to handle some larger and more complicated project work but with oversight at a moderate degree.
- Demonstrated ability to plan and organize validation activities among cross functional groups; capable of providing and maintaining status updates for process validation activities related to day-to-day operations or project work.
- Able to correctly assess large and complex change controls with an accurate understanding of the bigger picture implications of changes.
Key requirements:
- Bachelors’ Degree or equivalent in an engineering discipline (biomedical, chemical, biochemical, etc.), or a life science equivalent. A Master’s degree in a related field is a plus.
- Advanced (3+ years) experience in Bio/Pharma Industry
- Experience with process validation (PPQ, CPV) and/or aseptic process validation.
- Thorough knowledge of process validation life cycle (Stages I-III), validation protocols, generation and execution of manufacturing and laboratory equipment, clean process utilities and classified facilities.
- Uses experience and knowledge to solve problems, make decisions, and develop plans for the group. Makes recommendations for the department.
- Able to identify and respond to complex problems, interpret complex data and draw valid conclusions.
- Demonstrated experience in management of complex tasks and projects. Proficient at establishing clear and understandable directions and goals. Provides and implements suggested resolution to roadblocks. Able to prioritize own work and aid in setting group priorities.
- Strong communication and organizational skills.
- Intermediate knowledge of cell biology, adherent and suspension cell culture, bioreactor operation, chromatography operation, UF/DF, TFF, and aseptic filling. Work experience in viral vector product/process development or manufacturing is a plus.
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.