\\n Our customer is an innovative biopharmaceutical Big Pharma company. For an on-site assignment in the growing new commercial manufacturing site, we are looking for a Cleaning Validation Engineer. In this role you will ensure, that cleaning processes are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.

You

• pro-active and collaborative communication in French & English
• able to execute validations for cleaning across the site
• Co-ordinate activities interfacing with multiple sites, departments and external vendors

Your tasks

• Ensure cleaning 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 validation plans, protocols, reports, traceability matrix and summary reports
• Lead/participate to risk assessments and risk management teams
• Review change controls and maintenance interventions, evaluating the impact upon qualified systems & validated processes, and documents required actions
• 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
• Participates/lead projects and initiatives and contributes to continuous improvement exercises.

Your profile

• Degree in Engineering/Technical discipline or experience equivalent
• Experience (at least 5 years) in validation required, special focus on cleaning validation for small molecules
• Familiarity with current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11n, EU-GMP guidelines and GAMP
• Good communication skills in French & English with stakeholders and outside vendor groups
• Automation knowledge advantageous
• Team player: ability to interact effectively with team and customers
• Proactively identifies problems and recommends solutions

The Cleaning Validation Expert is supporting the development and implementation of strategies that ensure Global Commercial Supply is maintained\\n \\n \\n \\n \\n \\n

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