Validation Specialist - Cell Therapy

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 Validation Specialist Level 3 helps to lead team members to assess new and changing equipment and systems to ensure compliance with company policies, procedures and industry guidance. The Validation Specialist Level 3 will risk assess equipment/systems, review change requests and test scripts, draft protocols and initiate and review GMP documentation revisions. This position also provides guidance to junior team members. Specialist will be involved as the CGT Validation representative during small and large-scale projects 

Responsibilities

  • Perform all aspects of QMS process’ – Change Control, Deviations, CAPAs

  • Execute all responsibilities as Validation project lead for simple projects

  • Oversee/perform all CGT Validation qualification activities

  • Perform Validation Maintenance

  • Review/Revise CGT Validation SOPs

  • Perform review of Engineering documents (P&IDs, SOPs, Specifications, Submittals, etc.)

  • Assist with audits and inspections · Perform other duties as assigned

Key Requirements:

  • Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation

  • Strong written and oral communication skills

  • Strong organizational and time management skills

  • Experience with Quality Systems including: Document Management System (DMS),

  • Laboratory Information Management System (LIMS) and Trackwise system (Change Control, Deviations, CAPA, etc.).

  • Ability to prioritize tasks as needed to support the changing business demands.

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

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: R48592