Validation Specialist -Cell Therapy
QA (Quality Assurance) Equipment Validation exists to ensure all critical GMP (Good Manufacturing Practice) equipment and systems are validated and maintained in compliance with user requirements, process parameters and global regulatory guidelines. We provide 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.
Perform Equipment Validation Maintenance Quality Systems review and re-qualification activities to ensure GMP equipment is continuously maintained in a validated state. Schedule own tasks to be performed as well as tasks for Level 1 and Level 2 Specialist as determined by the Validation Manager
Perform change control assessments for GMP equipment and associated validation activities to ensure compliance with regulatory requirements
Program, organize, and maintain Validation equipment and supplies and train new personnel in these areas
Demonstrate a thorough understanding of biopharmaceutical manufacturing equipment and validation procedures for Installation Qualification (IQ), Steam-In-Place (SIP), Autoclaves, Clean Utilities, Shipping Validation, Temperature Mapping Controlled Storage Rooms and Equipment. Develop validation protocols from Validation plans and engineering documents.
Provide strong technical expertise 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 (Corrective Action, Preventative Action), etc.).
Perform other duties as assigned.
Bachelor’s degree in Science or technical discipline 2 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 (Corrective Action, Preventative Action), etc.).
Demonstrates ability to prioritize tasks as needed to support the changing business demands.
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.