Process Validation Engineer
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 Process Validation Engineer is responsible for the development of validation plans, qualification protocols, compiling and analyzing data, drafting summary reports, and reviewing validation documentation to ensure products are manufactured in accordance with applicable regulatory agencies, client’s requirements, and Lonza’ s specifications/requirements.
- 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 PV on project teams and interfaces with customer technical and quality representatives. Represents Process Validation on internal teams (e.g. DRB, CCC, and Daily Management System meetings).
- Participate in customer audits and regulatory inspections.
- Serves as the coordinator for quality Validation programs.
- Experienced with process validation (PPQ, CPV) and/or aseptic process validation.
- Able to work with minimal assistance and supervision on process validation discrepancies or investigations.
- Able to assess deviations that affect process validation with minimal assistance.
- Able to lead change controls for new product/process into the Lonza Houston facility and assess minor change controls with minimal assistance.
- Able to work with assistance and supervision on moderate CAPA that result from deviations, internal audits, protocol discrepancies, global quality audits or regulatory inspections.
- Bachelor’s degree in Chemical Engineering, Biochemical Engineering or other Life Sciences Degree. Advanced Degree preferred but not required.
- Strong Understanding of aseptic processing and techniques
- Experience in pharmaceutical, biotechnology, or related industry.
- Advanced understanding of Process Validation, Process Performance Qualification (PPQ), Continued Process Verification (CPV)
- GMP compliance knowledge
- Experience working with quality systems in a GMP facility
- The ability to interface and communicate directly with clients will be required.
- Strong technical writing skills
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.