Senior Validation Engineer
- Celgene Corporation
- Date de publication
Senior Validation Engineer
The Senior Validation Engineer is responsible for managing validation projects. A key member of the Manufacturing Technical Services team, this position will regularly work cross functionally with IT, Manufacturing, QA, QC, Logistics, Facilities, Drug Product Development and Vendors. Responsibilities include but are not limited to:
Ensure equipment, systems and processes are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
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, excluding global IT systems.
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.
Subject Matter Expert, SME, for Computer System Validation, (including data integrity).
Manage validation projects; including managing time, resources and budgets; own associated change controls.
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 Manufacturing Technical Services team.
- BS degree in Life Sciences, Computer Science, Chemistry, Engineering or equivalent
- Minimum 5 years experience in validation
- Minimum 2 years experience in managing validation projects
- Familiarity with current international regulatory regulations, cGxP requirements and best practises, including 21 CFR part 11, 210 and 211, Annex 11 to EU-GMP guidelines and GAMP
- Computer System Validation (including data integrity) would be an advantage
- Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems
- Good communication skills in English & French with facility, production, laboratory, technical operations, QA, and outside vendor groups
- Team player: ability to interact effectively with team and customers.