MSAT Cleaning Validation Expert

Your responsibilities:

• Lead and execute equipment cleaning validation activities, including protocol and report authoring for COP, CIP, USP, DSP, and buffer/media preparation systems.
• Support and perform cleaning validation execution, including parts washer COP validation.
• Own and support the SOP lifecycle (authoring, review, update, and approval) related to cleaning validation.
• Coordinate with R&D, Manufacturing, QC, and QA on development and validation of new or modified cleaning processes.
• Ensure compliant implementation of validated cleaning methods in routine manufacturing operations.
• Act as technical lead and coordinator in cross functional projects related to cleaning validation.
• Provide cleaning validation impact assessments for deviations, changes, and technical change requests (DRs, CRs, TCRs).
• Contribute to customer and regulatory inspections, including preparation and presentation of validation data and rationale.
• Support evaluation of customer requests and inquiries related to cleaning validation topics.

Your background:

• Degree in Life Sciences, Biotechnology, Chemical Engineering, or a related scientific discipline.
• Experience authoring and reviewing validation protocols, reports, and GMP SOPs.
• Strong cross functional collaboration skills, working with MSAT, QA, QC, Manufacturing, and R&D.
• Hands on experience with equipment cleaning validation (e.g. COP, CIP, USP, DSP, buffer/media preparation systems).
• Solid understanding of regulatory expectations (FDA, EMA) related to cleaning validation and contamination control.
• Ability to perform and assess cleaning validation impact assessments for changes and deviations (DRs, CRs, TCRs).