Develop, author, and execute Cleaning Validation Master Plans (CVMPs), risk assessments, and protocols (IQ / OQ / PQ or CVP).
Conduct and oversee cleaning validation and verification studies for manufacturing and laboratory equipment.
Establish and justify acceptance criteria based on toxicological, product, and equipment data.
Coordinate and support swab and rinse sampling and ensure analytical methods are validated and appropriate for residue detection.
Collaborate with Quality Assurance, Manufacturing, Engineering, and Analytical Development teams to ensure cleaning validation requirements are met.
Analyze data, prepare summary reports, and ensure documentation meets regulatory and internal quality standards.
Evaluate and approve cleaning procedures, ensuring consistency with validated parameters.
Participate in deviation investigations, change control, and CAPA processes related to cleaning systems.
Support ongoing cleaning verification programs and maintain a state of validation.
Provide technical input during equipment design, commissioning, and process transfer stages to ensure cleaning considerations are built into system design.
Required Qualifications
Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Microbiology, or related discipline.
5 7 years of experience in cleaning validation within pharmaceutical or biotech manufacturing environments.
Strong understanding of GMP, FDA, and EU regulatory requirements for cleaning validation.
Proven experience developing and executing cleaning validation protocols and reports.
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Validation Engineer • NC, United States
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