CSV Project Specialist

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 CSV Project Specialist coordinate and drive validation activities in computer systems projects in a GxP environment and will drive the creation and completion of important validation documentation throughout the duration of projects, including performing pre-reviews for LIQ Global System Managers and will participate in project teams as a core team member.

Key responsibilities:

  • Ensure that validation projects are successfully coordinated in cooperation with cross-functional project teams consisting of Lonza Internal and External personnel. Creation of validation deliverables planning in collaboration with quality manager.

  • Act as a conduit between the core project team / validation team members and the global information quality organization.

  • Review and comment for correction, in accordance with Lonza quality standards and SOPs, validation documents provided by the project team before approval by the respective QA managers.

  • Represent LIQ in coordination with local QA organizations for the project durations.

  • Act as deputy to the respective system quality manager during times of their absence or unavailability.

  • In cooperation with the global information quality managers, ensure the validation document packages are up to date and managed in an efficient and effective way, making use of the internal regulations and the defined risk-based approach. Inform quality manager and drive resolution of discrepancies and incidents during validation execution.

Key requirements:

  • Bachelor or equivalent qualification in Computer Science and/or vocational experience in Computer System Validation execution.

  • Experience with participation in validation projects relating to GMP processes and computer systems projects

  • Expertise in IT, IT Systems Validation and its application to GMP processes e.g. manufacturing process, laboratory and business systems

  • Knowledge of GMP documentation requirements for the validation of computer systems in the pharmaceutical industry

  • Project experiences

  • Good technical understanding and strong quality mindset

  • Good interpersonal skills and ability to interact positively with all functions in a complex project organization

  • Strong verbal and written communication skills with well-structured communication

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: R36553