Celgene International Sàrl
- Senior Validation Engineer
Paris
2012 - maintenant
As Senior Engineer, I am responsible for managing validation projects. As a key member of the Validation Services team, I regularly work cross functionally with Manufacturing, QA, Logistics, Facilities, Drug Product Development and Vendors.
-Subject Matter Expert for Cleaning Validation and Utilities Qualification.
-Ensure equipment, systems and processes are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their life-cycle.
-Author and when required review validation documents, including requirement specifications,
validation plans, protocols, reports, traceability matrix and summary reports
-Execute qualifications for all equipment and systems across the site, including QC, production, warehouse, facilities, equipment, utilities and computer system validation.
-Execute validations for all processes across the site, including cleaning processes, bulk process, packaging processes and warehouse / sampling processes.
-Participate to the development and maintenance of the local site procedures
-Lead risk assessments when required. Participate to risk assessments & risk management teams.
-Review change control documents, to evaluate impact on qualified systems and validated processes
-Manage validation projects; including managing time, resources and budgets
-Develop and justify the validation approach based on risk and a scientific rational
-Co-ordinate qualification and validation execution activities, including external vendors and
internal departments
-Maintain procedures governing validation to ensure they are in compliance with Corporate
policies and regulatory requirements
-Participate when required during internal and external audits for which they are a SME, by
answering questions, reviewing qualifications and validations with auditors, and providing documentation
-Establish and maintain effective relationships with internal team, customers and suppliers
-Provide mentoring and leadership to Validation Services team
