Process Validation Engineer III (Biotech)
At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia.
We strive to be the leading supplier using science and technology to improve the quality of life.
We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.
Process Validation Engineer III
The Process Validation Engineer III 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. The Process Validation Engineer will also be responsible for ensuring the validation of aseptic processes. This role also represents Process Validation on project teams and interfaces with customer technical and quality representatives. The Process Validation Engineer will also represent the department on internal teams (e.g. Deviation Review Boards, Change Control Boards, and Daily Management System meetings).
Develops validation plans, qualification protocols, compiles and anlyzes 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).
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.