Sterility Assurance Associate (Biotech)
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.
Join Lonza in Houston, TX as a Sterility Assurance Associate. This is an outstanding opportunity to contribute to a detailed Sterility Assurance Program in healthcare and life sciences. Be part of a premier team that is bold and determined to set high standards in sterility assurance and aseptic processing.
Key Responsibilities
Provide support to the development and implementation of the site Sterility Assurance Program.
Develop, document, and manage microbial control strategy for production processes, from incoming raw materials through final product release.
Assess facility and quality systems' compliance with internal requirements and appropriate regulations, participating in the development of action plans to address deficiencies and improve quality processes.
Provide sterility expertise to support cGMP documentation including, but not limited to: SOPs, batch records, media fill/APS protocols and reports, validations, specifications, EMIRs, Deviations, CAPAs, and Change Controls related to aseptic processing.
Support regulatory and customer audits as the Aseptic Sterility Assurance subject matter expert.
Provide mentorship and support for Operations and QA/QC specialists.
Key Requirements
Associate Degree in Life Sciences or equivalent experience.
Proven experience with regulations (US, EU, and other).
Highly experienced in Bio-pharmaceutical manufacturing and/or aseptic processing working in a GMP environment.
Advanced experience in Aseptic Processing.
Become part of an ambitious team dedicated to improving healthcare and life sciences. At Lonza, we believe in empowering our employees to take ownership of their careers, encouraging an environment where ideas can flourish and truly make a difference.
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.
