Cleaning Validation Specialist

We are seeking a Cleaning Validation Specialist to support equipment upgrade projects within a biologics manufacturing facility. The ideal candidate will have hands‑on experience executing cleaning validation activities, authoring validation documentation, and ensuring compliance with cGMP standards throughout the validation lifecycle.

• Author and execute Cleaning Validation protocols, reports, and documentation using Kneat Gx or similar electronic validation systems.
• Perform on-site cleaning validation activities including swab/rinse sampling, data collection, and protocol execution.
• Support qualification of centrifuges, CIP skids, transfer panels, heat exchangers, and other process equipment.
• Investigate validation deviations, coordinate corrective actions, and prepare validation summary reports.
• Collaborate with QA, Engineering, Manufacturing, and Validation teams to ensure successful project execution.
• Ensure compliance with cGMP, FDA regulations, and validation documentation requirements while supporting inspection readiness.

• Bachelor's degree in Engineering, Life Sciences, or related field (or equivalent experience).
• Experience performing Cleaning Validation in pharmaceutical, biotech, or biologics manufacturing environments.
• Hands‑on experience with Kneat Gx or similar validation management systems.
• Strong knowledge of cleaning validation, GMP documentation, CIP/SIP systems, and process equipment qualification.