Required Skills:
• Prior experience as a cleaning validation engineer in a GMP CDMO environment
• Previous experience managing cleaning validation protocols in a facility that has multiple
product lines (produces multiple products)
• Previous experience partnering with the validation auditor team and has an in-depth knowledge
of the auditor sample collection process:
o Sampling methods (Swab and Rinse)
o Visual Inspection
o Documentation/data collection
• Prior experience working in the quality lab or in-depth understanding of the lab equipment used
to analyze collected samples:
o Understanding of what equipment is used for which tests. (HPLC, Mass Spec, GC, pH,
Total Organic Carbon)
o Previous experience with the timelines for sample testing
o Prior experience with the volume of samples that can be tested
Desired Skills:
• Experience with Kneat