Lonza
MSAT Cleaning Validation Lead
Lonza, Tampa, Florida, us, 33646
Today, Lonza is a global leader in life sciences operating across five 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 MSAT Cleaning Validation Lead will be responsible for ownership of the cleaning verification and validation program at the Lonza Tampa facilities. This individual will work with functional units within the Lonza organization to develop a compliant cleaning validation program, and will be responsible for managing, planning and executing cleaning verification and validation projects.
Key Accountabilities:
Leads the development, lifecycle review, and management of the cleaning validation program and strategy.Leads the cleaning validation activities (planning, test protocol generation, execution, and report generation).Evaluation of new products, new equipment, materials of construction as used in production and packaging operations for clinical and commercial programs with shared equipmentEnsures that cleaning validation projects are compliant with site and corporate policies and procedures, as well as regulatory requirements (US domestic and international)Supports the development of cleaning procedures and batch-related cleaning documentation such as cleaning validation master plan, SOPs, equipment grouping docsCoordinates and conducts risk assessments related to cleaning methodologies and validation.Training of personnel in cleaning procedures and methodology.Works with multiple functional groups, both within the Lonza Tampa site and the larger Lonza organization, in the development and execution of the cleaning validation program.Represents MSAT in project teams.Recognized as subject matter expert in Cleaning Verification and Validation principles.Leads investigations to support root cause analysis, product impact assessment, and effective Corrective and Preventive Action definition.Supports internal and external audits as cleaning validation representative from MSAT.Key Requirements:
Bachelor's degree or equivalent experience is required.Mastery of cleaning verification and validation principles, practices, and methodologies.7+ years of experience in cleaning validation within a pharmaceutical or medical device manufacturing environment is required. Pharmaceutical manufacturing experience preferred.Project management experience strongly preferred.Excellent organizational, time management, and verbal / written communication 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.
The MSAT Cleaning Validation Lead will be responsible for ownership of the cleaning verification and validation program at the Lonza Tampa facilities. This individual will work with functional units within the Lonza organization to develop a compliant cleaning validation program, and will be responsible for managing, planning and executing cleaning verification and validation projects.
Key Accountabilities:
Leads the development, lifecycle review, and management of the cleaning validation program and strategy.Leads the cleaning validation activities (planning, test protocol generation, execution, and report generation).Evaluation of new products, new equipment, materials of construction as used in production and packaging operations for clinical and commercial programs with shared equipmentEnsures that cleaning validation projects are compliant with site and corporate policies and procedures, as well as regulatory requirements (US domestic and international)Supports the development of cleaning procedures and batch-related cleaning documentation such as cleaning validation master plan, SOPs, equipment grouping docsCoordinates and conducts risk assessments related to cleaning methodologies and validation.Training of personnel in cleaning procedures and methodology.Works with multiple functional groups, both within the Lonza Tampa site and the larger Lonza organization, in the development and execution of the cleaning validation program.Represents MSAT in project teams.Recognized as subject matter expert in Cleaning Verification and Validation principles.Leads investigations to support root cause analysis, product impact assessment, and effective Corrective and Preventive Action definition.Supports internal and external audits as cleaning validation representative from MSAT.Key Requirements:
Bachelor's degree or equivalent experience is required.Mastery of cleaning verification and validation principles, practices, and methodologies.7+ years of experience in cleaning validation within a pharmaceutical or medical device manufacturing environment is required. Pharmaceutical manufacturing experience preferred.Project management experience strongly preferred.Excellent organizational, time management, and verbal / written communication 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.