QA Validation Specialist (CV)

United States, Portsmouth (New Hampshire)

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.

The QA Cleaning Validation Specialist partners with other members of the staff to perform activities with respect to qualifications and required documents for cleaning procedures employed at the Lonza Portsmouth location with the objective of ensuring the processes meet acceptance criteria and comply with regulatory guidelines. The Validation Specialist performs protocol executions and completes associated GMP (Good Manufacturing Process) documentation. The specialist is still acquiring new skills and is expected to partner with more experienced staff and the department manager to develop skills and knowledge.

Key responsibilities:

  • Develops moderately complex Cleaning Validation protocols for execution. This includes protocols for automated, semi-automated and manual cleaning processes.  This also includes preparation of sample labels using LIMS.

  • Schedules and tracks CV protocol executions. This includes coordination with Scheduling and Manufacturing.

  • Performs protocol close-out activities including drafting of summary reports, obtaining sample results via LIMS, maintaining execution tracker and discrepancy reports generation.

  • Works to identify efficiencies in Validation program approach. Work to apply lessons learned and stay informed of industry regulatory changes as it applies to cleaning validation.

  • Performs assigned Quality Systems activities including: Document Management System (DMS), Laboratory Information Management System (LIMS) and Trackwise system (Change Control, Deviations, CAPA, etc.).

  • Continually works to increase knowledge of biopharmaceutical manufacturing equipment and validation procedures for Operational Qualifications (OQ) and Performance Qualifications (PQ).

Key requirements:

  • Bachelor’s Degree, Science or technical discipline

  • Strong technical writing skills and ability to document all work in a meticulous, accurate, and timely manner. 

  • Strong written and oral communication skills and ability to work interdepartmentally in an effective manner to carry out daily duties. 

  • Strong organizational and time management 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.

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: R37044