Sterility Assurance Associate
JCW Group, Montgomery, AL, United States
Sterility Assurance Associate – 3-6 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 hands‑on support and technical guidance to ensure sterile manufacturing operations meet GMP requirements, regulatory expectations, and industry best practices. The associate will collaborate cross‑functionally with Manufacturing, Quality Control, and Technical Services teams to strengthen programs including aseptic training, aseptic process simulations (media fills), and environmental monitoring.
Key Responsibilities
Provide technical support for aseptic processing, contamination control, process validation, and lifecycle documentation.
Partner with Manufacturing and Quality teams on validation and qualification activities for facilities, equipment, utilities, and processes.
Author and maintain SOPs, validation plans, and contamination control documentation.
Support risk assessments, gap assessments, remediation activities, and regulatory inspection readiness.
Oversee validation and requalification activities, including media fills, sterilization cycles, and aseptic process validations.
Assist investigations, including root cause analysis and CAPA related to sterility or contamination events.
Required Qualifications
Bachelor’s degree in Microbiology, Biology, Engineering, or related scientific discipline.
Knowledge of global GMP and regulatory standards (FDA, EU GMP, etc.).
Experience supporting sterile or aseptic manufacturing environments.
Preferred Qualifications
Experience in parenteral, biologics, or vaccine manufacturing.
Hands‑on experience with environmental monitoring, aseptic processing, and sterile gowning practices.
Experience performing sterile manufacturing risk assessments and remediation initiatives.
Familiarity with Lean or Six Sigma methodologies.
Strong organizational and communication skills; able to manage multiple priorities in a fast‑paced, regulated environment.
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We are seeking a Sterility Assurance Associate to support sterility assurance and contamination control initiatives within a biologics manufacturing environment. This role will provide hands‑on support and technical guidance to ensure sterile manufacturing operations meet GMP requirements, regulatory expectations, and industry best practices. The associate will collaborate cross‑functionally with Manufacturing, Quality Control, and Technical Services teams to strengthen programs including aseptic training, aseptic process simulations (media fills), and environmental monitoring.
Key Responsibilities
Provide technical support for aseptic processing, contamination control, process validation, and lifecycle documentation.
Partner with Manufacturing and Quality teams on validation and qualification activities for facilities, equipment, utilities, and processes.
Author and maintain SOPs, validation plans, and contamination control documentation.
Support risk assessments, gap assessments, remediation activities, and regulatory inspection readiness.
Oversee validation and requalification activities, including media fills, sterilization cycles, and aseptic process validations.
Assist investigations, including root cause analysis and CAPA related to sterility or contamination events.
Required Qualifications
Bachelor’s degree in Microbiology, Biology, Engineering, or related scientific discipline.
Knowledge of global GMP and regulatory standards (FDA, EU GMP, etc.).
Experience supporting sterile or aseptic manufacturing environments.
Preferred Qualifications
Experience in parenteral, biologics, or vaccine manufacturing.
Hands‑on experience with environmental monitoring, aseptic processing, and sterile gowning practices.
Experience performing sterile manufacturing risk assessments and remediation initiatives.
Familiarity with Lean or Six Sigma methodologies.
Strong organizational and communication skills; able to manage multiple priorities in a fast‑paced, regulated environment.
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