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.
About Intellectt Inc
Welcome to Intellectt, where the convergence of emerging technologies, domain expertise and innovation drives excellence. Intellectt is a leading provider of Engineering, IT, and consulting services. Our dedication to customer success and our ability to scale on demand have propelled us to become one of the fastest-growing companies in the technology services segment in the US, over the last five years. Intellectt offers deep domain expertise in manufacturing, medical devices, healthcare, banking, financial services and other industries, alongside robust capabilities in emerging technologies like Artificial Intelligence (AI), NLP, Block Chain, Cloud and others. This unique combination enables our customers to navigate the complexities of today's technology and business landscape in order to achieve their goals.
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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.
About Intellectt Inc
Welcome to Intellectt, where the convergence of emerging technologies, domain expertise and innovation drives excellence. Intellectt is a leading provider of Engineering, IT, and consulting services. Our dedication to customer success and our ability to scale on demand have propelled us to become one of the fastest-growing companies in the technology services segment in the US, over the last five years. Intellectt offers deep domain expertise in manufacturing, medical devices, healthcare, banking, financial services and other industries, alongside robust capabilities in emerging technologies like Artificial Intelligence (AI), NLP, Block Chain, Cloud and others. This unique combination enables our customers to navigate the complexities of today's technology and business landscape in order to achieve their goals.