Validation Specialist -Cell Therapy
United States, Portsmouth (New Hampshire)
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.
Quality Assurance Cell Therapy Validation Specialist supports the Cell Therapy organization in ensuring that all critical GMP equipment and systems are qualified/validated, and maintained in a qualified/validated state in compliance with user requirements, process parameters and global regulatory guidelines. At this level, the specialist is still developing and acquiring skills to more effectively support Cell Therapy Operations, Quality Assurance, our clientele, and regulatory bodies with scientifically sound, documented evidence that our systems and processes will perform as required so they can be assured of a quality, compliant manufacturing environment. At level 2 the specialist may escalate questions or issues to the manager or more experienced members of the team, while also being expected to onboard and support less experienced staff.
- Perform Equipment Validation Maintenance Quality Systems review and re-qualification activities to ensure GMP (Good Manufacturing Processes) equipment is continuously maintained in a validated state.
- Program, organize, and maintain Validation equipment and supplies including Kaye Validators and Kaye Valprobes.
- Demonstrate a general understanding of cell therapy manufacturing equipment and validation procedures for Clean Rooms, Aseptic Processing, Autoclaves, Clean Utilities, Temperature Mapping Controlled Storage Rooms and Equipment. Develop validation protocols from Validation plans and engineering documents.
- Develop validation protocols from Validation plans and engineering documents.
- Provide technical support when reviewing and approving SOPs, protocols, change controls, deviations.
- Perform assigned Quality Systems activities including: Document Management System (DMS), Laboratory Information Management System (LIMS) and Trackwise system (Change Control, Deviations, CAPA, etc.).
- Perform other duties as assigned.
- Bachelor’s degree in Science or technical discipline intermediate or more years of industry experience Good understanding of cell therapy manufacturing equipment and validation procedures for Clean Rooms, Aseptic Processing, Autoclaves, Clean Utilities, Temperature Mapping Controlled Storage Rooms and Equipment.
- Solid technical writing skills and ability to document all work in a meticulous, accurate, and timely manner.
- Solid written and oral communication skills and ability to work interdepartmentally with some basic supervision in an effective manner to carry out daily duties.
- Understand how to write discrepancies and give a root cause analysis..
- Solid organizational and time management skills
- Experience with Quality Systems including: Document Management System (DMS), Laboratory Information Management System (LIMS) and Trackwise system (Change Control, Deviations, CAPA, etc.).
- Demonstrates ability to prioritize tasks as needed to support the changing business demands.
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 it is 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.