Sterility Assurance Associate – 6 Month Contract
We are seeking a Sterility Assurance Associate to support sterility assurance and contamination control initiatives within a biologics manufacturing environment. This role will provide technical oversight and hands-on support to ensure manufacturing operations align with GMP requirements, regulatory expectations, and industry best practices.
The consultant will work cross-functionally with Manufacturing, Quality Control, and Technical Services teams to strengthen sterility assurance programs, including aseptic training and qualification, aseptic process simulations (APS/media fills), and environmental monitoring programs.
Provide technical support and subject matter expertise for process validation, aseptic processing, cleaning validation, and contamination control strategies, ensuring proper lifecycle documentation.
Partner with manufacturing and quality teams to define and execute validation and qualification requirements for facilities, equipment, utilities, and manufacturing processes.
Author and support the development of SOPs, validation plans, and contamination control documentation related to sterile and aseptic manufacturing processes.
Support risk assessments, gap assessments, and remediation activities related to sterility assurance programs.
Assist with regulatory inspection readiness, including documentation review and training support.
Provide oversight during validation and requalification activities, including media fills, sterilization cycles, media holds, and aseptic process validations.
Support investigation activities, including root cause analysis (RCA) and CAPA implementation related to sterility assurance or contamination events.
Bachelor’s degree in Engineering, Microbiology, Biology, or a related scientific discipline.
Working knowledge of global GMP and regulatory standards, including FDA, EU GMP, and other applicable regulatory frameworks.
Experience supporting sterile or aseptic manufacturing environments.
Experience with parenteral, biologics, or vaccine manufacturing operations.
Hands-on experience with environmental monitoring programs, aseptic processing, and sterile gowning practices.
Experience conducting sterile manufacturing risk assessments and remediation initiatives.
Familiarity with Lean manufacturing or Six Sigma principles.
Strong organizational and communication skills with the ability to manage multiple priorities in a fast-paced, regulated environment.
