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).
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