Validation Engineer/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 Validation Team supports ongoing operations at the Portsmouth NH site.  The site is conveniently located on the seacoast of New Hampshire, just 60 miles North of Boston, MA. The focus of the Validation team is to identify or create industry best practices and implement these within the framework of existing GAMP (Good Automated Manufacturing Process) regulations. Responsibilities will include risk assessing systems, reviewing change requests and test scripts, drafting protocols and initiating and reviewing GMP (Good Manufacturing) documentation revisions as well as ownership of department procedures. 

A role in Validation could be in Computer System Validation, Cleaning Validation or Equipment Validation. The level of the role will be dependent on candidate skills and experience.

Key responsibilities:

  • Develops protocols for execution. This includes protocols for automated, semi-automated and manual processes.  This also includes preparation of sample labels using LIMS. This also includes performing review/approval of pre-execution protocols for other validation specialists.

  • Schedules and tracks 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. This also includes performing final review/approval of post-execution protocols for other validation specialists.

  • 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 (Corrective Action, Preventative Action), etc.).

  • Acts as point person for customer communications as assigned.

  • Participates in Audits and Inspections.

  • Provides SME level expertise.

  • Perform other duties as assigned.

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. 

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

  • Excellent organizational and time management skills.

  • System Matter Expert (SME) level of at least one; Cleaning Program; Equipment Validation or Computer Systems Validation (CSV) knowledge.

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: R41120