Our Gi Life Sciences team is actively seeking a Cleaning Validation Expert for a company active in the chemical and pharmaceutical industry.

Mission:

Provide the necessary technical expertise and operational support for equipment cleaning validation activities to ensure GMP compliance, operational readiness and successful regulatory inspections.

Tasks:

• Lead and execute equipment cleaning validation activities, including drafting protocols and reports for COP, CIP, USP, DSP systems as well as buffer preparation and media systems.
• Support and carry out the execution of cleaning validations, notably the COP validation of the parts washer.
• Manage the lifecycle of SOPs related to cleanup validation (creation, review, update, approval).
• Collaborate closely with R&D, Production, QC and Quality Assurance for the development and validation of new cleaning processes or modified processes.
• Ensure the compliant implementation of validated cleaning methods in routine manufacturing operations.
• Act as a technical expert and coordinator in cross-functional projects related to cleaning validation.
• Carry out cleaning validation impact assessments for discrepancies, modifications, and change requests (DR, CR, TCR).
• Actively contribute to customer and regulatory inspections, including the preparation, presentation and justification of validation data.
• Manage customer requests and questions related to the validation aspects of cleaning.
• Ensure consistency and supervision of cleaning validation activities.

Profile :

• Degree in life sciences, biotechnology, chemical engineering or equivalent scientific field.
• Confirmed practice of drafting and reviewing validation protocols, technical reports and standard operating procedures (SOPs) in a GMP environment.
• Proven experience of at least 5 years in validating equipment cleaning, ideally in a GMP environment.
• Excellent understanding of applicable regulatory requirements, including those from FDA and EMA authorities.
• Demonstrated ability to work effectively with MSAT, QA, QC, Manufacturing and R&D teams.
• Structured, rigorous and detail-oriented approach with excellent documentation and data analysis skills.
• Ability to act as a technical expert and coordinate activities in a project environment.
• Fluent in English; knowledge of German an asset.