Be the driving force behind seamless logistics for a global CMO, where precision and efficiency are key to supporting world-class manufacturing.

Proclinical is seeking an MSAT Cleaning Validation Expert to provide technical expertise and operational support for equipment cleaning validation activities. This role focuses on ensuring GMP compliance, operational readiness, and success during regulatory inspections. You will collaborate across multiple functions and act as a subject matter expert in cleaning validation processes.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

• Lead and execute equipment cleaning validation activities, including protocol and report authoring for COP, CIP, USP, DSP, and buffer-media preparation systems.
• Perform cleaning validation execution, including parts washer and COP validation.
• Manage the SOP lifecycle by authoring, reviewing, updating, and approving documents related to cleaning validation.
• Coordinate with R&D, Manufacturing, QC, and QA teams to develop and validate new or modified cleaning processes.
• Ensure validated cleaning methods are implemented compliantly in routine manufacturing operations.
• Act as a technical lead and coordinator in cross-functional projects related to cleaning validation.
• Provide 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.
• Ensure consistency and oversight of cleaning validation activities across the organization.

Key Skills and Requirements:

• Background in Life Sciences, Biotechnology, Chemical Engineering, or a related scientific discipline.
• Proven experience in GMP cleaning validation within biopharmaceutical or pharmaceutical manufacturing environments.
• Hands-on experience with equipment cleaning validation, including COP, CIP, USP, DSP, and buffer-media preparation systems.
• Solid understanding of regulatory expectations (FDA, EMA) related to cleaning validation and contamination control.
• Strong documentation and data analysis skills with a structured, detail-oriented working style.
• Ability to perform and assess cleaning validation impact assessments for changes and deviations.
• Effective cross-functional collaboration skills with MSAT, QA, QC, Manufacturing, and R&D teams.
• Fluent in English; German language skills are an advantage.
  

If you are having difficulty in applying or if you have any questions, please contact Olivier Worch at o.worch@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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