Manager, Validation (Cell & Gene 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.

The Validation Manager leads and provides oversight for Validation activities at Lonza Portsmouth's Cell Therapy and Gene Technologies manufacturing asset. Ensures that manufacturing related GMP systems and controls meet Global Quality standards and applicable regulatory requirements regarding qualification and validation. Supports aseptic processing simulations and facility cleaning validations. This role is accountable for the manufacturing asset's master validation plan, validation deployment strategies, and team leadership for equipment and utilities qualification/validation, computerized systems validation.

Key Accountabilities:

  • Develop and lead the overall validation master planning for cell therapy and gene technologies.
  • Partner with manufacturing, engineering, sterility assurance, and MSAT teams to ensure qualification activities are performed on time and compliant to global standards and regulatory requirements.
  • Author, Review and approve validation protocols and summary reports.
  • Build and maintain expertise in qualification/validation within the CGT Validation team via full time employees and contract resources.
  • Represent the Cell and Gene Technologies manufacturing asset for data integrity programs globally and locally. Oversee the development and deployment of data integrity remediation programs at CGT Portsmouth.
  • Support quality assurance activities as required.

Key Requirements:

  • Bachelor’s Degree required. Preferred area of study in life science or engineer.
  • Data Integrity experience
  • Sterile manufacturing experience (drug product, formulation filling)
  • GAMP 5 experience
  • Protocol authoring experience
  • Experience with people management and project management
  • Experience in Quality Operations or Quality systems GMP environment.  
  • Detailed knowledge and understanding of validation programs and regulatory requirements, biopharmaceutical bulk drug substance manufacturing and quality operations.
  • Strong knowledge in the application of cGMP requirements, biomanufacturing process and relevant manufacturing equipment.
  • Understanding of validation /qualification principles, industry practices and standards with ability to apply these to GMP operations.
  • Demonstrated ability to lead teams of diverse skill sets, make sound decisions regarding evaluation of validation programs and ability to influence at various levels in a cross-functional organization.

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.

Reference: R29976
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