Engineering Jobs in Kennebec County, ME

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.