Our client is seeking an experienced
Sterility 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.
What We're Looking For:
- 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
Disclosure:
This posting represents an active and genuine vacancy with one of 3 Step Recruitment’s clients and is not for speculative or pipeline recruitment.
3 Step Recruitment and/or our Clients may use, from time to time, AI-assisted tools to support the screening and evaluation of applications; however, these tools are not intended to replace human judgement or decision-making in the hiring process.
