Sterility Assurance Associate
JCW Group
Posted: 06/03/2026 Location: Winslow, Maine, United States Job type: Contract
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 .
Key Responsibilities
- 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 .
Apply Now
Vacancy posted 17 hours ago
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