Senior Validation Manager
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.
Lonza Houston has an exciting opportunity for a Senior Validation Manager. This individual will be responsible for developing and maintaining the equipment/system validation program at Lonza Houston. This role will identify and implement industry best practices through an extensive industry network and detailed knowledge of applicable regulations and best practices. Will be responsible for the authoring site procedures, project plans, validation templates and other documents for support of the validation program. This individual will manage a team of validation engineers including both FTE’s (8) and contractors (7). This role will also oversee the Quality Engineering Group.
The responsibility of project scoping will require collaboration with experienced members of Validation, Engineering, Operations and Quality Assurance (QA) teams to identify road blocks and additional efficiencies. Additional daily responsibilities include performing and documenting risk assessments of systems and processes, assessing change proposals, drafting protocols, evaluating deviations/change controls and initiating revisions of GMP documentation.
- Execute all responsibilities as the validation owner for significant site and process improvement projects, to ensure compliance to appropriate regulatory requirements and industry standards while maximizing efficiency
- Performs all aspects of QMS processes such as deviations, CAPA’s and change controls
- Oversee the validation lifecycle activities
- Manage, train and coach validation team
- Revise and maintain validation program SOP’s
- Function as validation SME during inspections and audits
- Lead the Quality Engineering Team
- Bachelors in Engineering or Management
- Highly experienced within Quality Validation
- Strong understanding of the importance of a sound GMP Validation Program
- Strong understanding of a biopharmaceutical manufacturing facility including the common types of equipment that make up upstream and downstream processing
- Demonstrated leadership skills as well as team building and mentoring skills
- Previous experience leading multi-functional professionals
- Is able to use experience and knowledge to solve problems, make decisions or make plans for their area
- Able to identify and respond to complex problems, interpret complex data and draw valid conclusions
- Demonstrated experience in management of complex tasks and projects
- Strong communication skills as will communicate regularly with members of other departments and customers
- Knowledge of SAP and Trackwise systems a plus
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.