Cleaning Validation Specialist

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 QA (Quality Assurance) Cleaning Validation Specialist supports the department by performing many of the activities associated with the qualification and required documentation for cleaning validation procedures utilized at Lonza Portsmouth. The specialist must ensure the procedures adhere to acceptance criteria and comply with regulatory guidelines. At this level the specialist is expected to have a strong grasp of nearly all duties within the department but is still developing their skills and knowledge of the more advanced tasks. They may also serve as a resource for less experienced staff.

Key Responsibilities:

  • Develops 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. This also includes performing review/approval of pre-execution protocols for other validation specialists.
  • 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. 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, etc.).
  • Acts as point person for customer communications as assigned.
  • Mentor and/or train junior level specialists.
  • Participates in Audits and Inspections.

Key Requirements:

  • Experience in cleaning validation within in a regulated manufacturing environment. Biotechnology or similar industry preferred.
  • Working experience with inspections and audits.
  • 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 Cleaning Program knowledge. Experience implementing a cleaning program a plus.

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: R24505