At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia.
We strive to be the leading supplier using science and technology to improve the quality of life.
We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.
Do you want to help us as we shape the future of this great organization?
Job Description Summary
Validation Specialist III
The QA Cleaning Validation Specialist Level 3 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 Accountabilities and Duties:
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.
Mentors Level 1 and 2 Specialists.
Participates in Audits and Inspections.
Provides SME level expertise.
Perform other duties as assigned.
Minimum Required Qualifications/Skills:
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.
Provides training to other team members
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.