Cleaning Validation Engineer
Job Title: Cleaning Validation EngineerLocation: Glendale, CA (On-Site) Duration: Long-Term Contract Job SummaryWe are seeking multiple experienced Cleaning Validation Engineers to support a biotechnology client facility in Glendale, CA. The ideal candidates will have strong experience in cleaning validation within regulated pharmaceutical or biotechnology environments, including protocol development, execution, residue analysis, and regulatory compliance activities.Key ResponsibilitiesDevelop, execute, and review cleaning validation protocols, reports, and risk assessments in compliance with cGMP, FDA, EMA, and other regulatory standards. Establish scientifically justified cleaning acceptance criteria, including MACO calculations and PDE-based cleaning limits. Perform and document residue sampling activities using swab and rinse sampling techniques. Conduct visual inspection assessments to verify equipment cleanliness and validation effectiveness. Collaborate with Manufacturing, Quality Assurance, and Engineering teams to coordinate validation activities during production operations. Analyze laboratory residual testing data and evaluate results to confirm cleaning process effectiveness. Investigate deviations, nonconformities, and cleaning failures, and support CAPA implementation activities. Support equipment commissioning activities and optimize cleaning processes for manufacturing operations. Participate in change control activities related to equipment modifications, process updates, and new product introductions. Develop, revise, and maintain SOPs and related cleaning validation documentation. Ensure all validation documentation is audit-ready and compliant with internal quality standards and global regulatory expectations. Required QualificationsBachelor’s degree or higher in Engineering, Chemistry, Pharmaceutical Sciences, or a related scientific discipline. Minimum 4+ years of cleaning validation experience within Biotechnology or Pharmaceutical manufacturing environments. Strong understanding of cleaning validation principles, including MACO calculations, PDE-based limits, and recovery studies. Experience developing and executing validation protocols and technical reports. Strong technical writing, analytical, and troubleshooting skills. Ability to interpret complex validation and laboratory data. Excellent communication and cross-functional collaboration abilities. Familiarity with validation lifecycle and quality management systems such as TrackWise, Kneat, Veeva, or similar platforms is preferred.