Description

Our Gi Life Sciences team is actively seeking a Cleaning Validation Expert
Cleaning Validation Expert
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.
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