Sterility Assurance Lead

Our client is seeking an experiencedSterility Assurance Subject Matter Expert (SME) to support a major program and associated projects at its Illinois location.

This is an opportunity for a seasoned pharmaceutical professional to apply their expertise in sterility assurance, aseptic processing and contamination control to support regulatory compliance and technical project execution.

Key Responsibilities:

• Provide technical expertise in sterility assurance, aseptic processing and contamination control strategies.
• Interpret and translate EU GMP Annex 1 requirements, global standards and SOPs into practical, actionable technical requirements.
• Conduct and support gap assessments and risk assessments, identifying technical gaps and recommending solutions.
• Review project requirements, scope and proposed solutions to ensure alignment with sterility assurance and contamination control requirements.
• Collaborate with program stakeholders and project teams to support implementation within existing pharmaceutical manufacturing facilities.

• 10+ years of relevant experience preferred.
• Strong expertise in sterility assurance, aseptic processing, contamination control strategies and pharmaceutical manufacturing.
• Demonstrated knowledge of EU GMP Annex 1 and its practical application in existing manufacturing facilities.
• Experience with technical assessments, regulatory requirements and cross-functional project support.

• Compensation: $140K–$170K USD