Sterility Assurance Associate

Sterility Assurance Associate – 6 Month ContractWe are seeking a Sterility Assurance Associate to support sterility assurance and contamination control initiatives within a sterile/aseptic manufacturing environment. This consultant will partner with Manufacturing, Quality, and Technical Services teams to ensure compliance with GMP and regulatory expectations while strengthening site sterility assurance programs.Key ResponsibilitiesProvide SME support for sterility assurance, aseptic processing, contamination control, and cleaning/process validation activities.Support aseptic process simulations (media fills), environmental monitoring programs, and sterile gowning practices.Assist with validation and qualification activities for manufacturing processes, equipment, and sterilization cycles.Author and maintain SOPs, validation documentation, and contamination control strategies.Conduct risk assessments, gap assessments, and remediation activities related to sterile manufacturing operations.Support deviations, investigations, root cause analysis, and CAPA implementation.Assist with regulatory inspection readiness and GMP compliance initiatives.QualificationsBachelor's degree in Engineering, Microbiology, Biology, or related scientific field.Experience working in sterile, aseptic, biologics, or parenteral manufacturing environments.Familiarity with GMP regulations (FDA, EU GMP) and sterile manufacturing best practices.Strong ability to work cross-functionally in a fast-paced, regulated environment.