Cleanroom Qualification/Validation Engineer (10-month contract)

• Title : Cleanroom Qualification/Validation Engineer
• Duration : 10 months
• Location : Tolochenaz

• Develop, validate, and implement methods for managing controlled environments.
• Establish controlled environment strategies, especially during changes in manufacturing lines or as part of improvement projects.
• Develop sampling plans for controlled environments, including particle measurements and utilities such as purified water, compressed air, gas, and others.
• Plan and oversee the qualification and annual requalification of cleanrooms, with a strong focus on classified areas.
• Write or maintain Process Failure Mode and Effects Analysis (pFMEA) documents.
• Responsible for defining and overseeing the cleaning validation strategy.
• Review biological and microbiological test results and conduct investigations when necessary.
• Coordinate microbiology testing with external suppliers to ensure timely and accurate results.
• Lead improvement projects aimed at optimizing laboratory processes.
• Manage non-conformities related to the controlled environment, laboratory procedures, or cleanroom qualifications.
• Ensure compliance with ISO standards such as ISO 14644 (Cleanrooms and associated controlled environments) and ISO 8573 (Compressed air).
• Coordinate and participate in activities during production shutdowns, including qualification/validation plan development and report writing, follow-up on activities, and non-conformity management.

Your profile

• Engineering degree (preferably in microbiology, HVAC, or cleanroom management).
• Minimum 2 years of experience in a similar role, particularly in cleanroom and classified area qualification and requalification.
• Experience in HVAC systems (purified water, compressed air, gas, etc.) and cleanroom operations.
• Proficiency in French and English.
• Strong background in managing non-conformities, qualification/validation reports, and continuous improvement.
• Hands-on experience in routine microbiological activities, including reviewing results and leading investigations.