Cleaning Validation Expert Pharma Switzerland Job in Montbéliard, Switzerland

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.

Cleaning Validation Expert Pharma Switzerland Job Description

One year contractor in FRENCH speaking part of Switzerland
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

• 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.

Cleaning Validation Expert Pharma Switzerland Job Requirements

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

Cleaning Validation Expert Pharma Switzerland Application Information

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Cleaning Validation Expert Pharma Switzerland Summary

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