Senior Contamination Control / Cleaning SME
About the role
Job Summary Seeking a Senior Contamination Control / Cleaning SME to assess and improve contamination control, cleaning validation, disinfection programs, and environmental monitoring systems within GMP-regulated pharmaceutical, biotechnology, or sterile manufacturing environments.
Key Responsibilities Conduct contamination control and cleaning program gap assessments. Evaluate cleanroom cleaning, disinfection, and environmental monitoring practices. Review and improve cleaning validation and contamination control strategies. Update cleaning and disinfection procedures, qualification programs, and challenge studies. Develop corrective action plans and support implementation activities. Ensure compliance with FDA, Health Canada, EU GMP Annex 1, and GMP requirements.
Required Qualifications 8+ years of contamination control experience in pharmaceutical, biotech, sterile manufacturing, or cleanroom environments. Strong expertise in Cleanroom Operations, Cleaning Validation, Disinfection Programs, Environmental Monitoring, and Aseptic Processing. Experience leading contamination control remediation or compliance improvement initiatives. Strong knowledge of FDA, Health Canada, EU GMP Annex 1, and current GMP regulations.