Sterility Assurance SME - EU Annex 1 Expert (On-Site)

i-Pharm GxP; Illinois; Presencial; USD 170 000 - 230 000; Tempo integral

Resumo da oferta

i-Pharm GxP is seeking a Sterility Assurance Subject Matter Expert (SME) to support EU Annex 1 compliance and remediation programmes at a leading biopharmaceutical site in Illinois, USA. The role focuses on aseptic processing, contamination control, cleanroom operations, and Annex 1 implementation.

The SME will work with Quality, Engineering, Manufacturing, Validation, and Global Sterility Assurance teams to identify gaps, design remediation strategies, and drive compliant site improvements

Qualificações

• Bachelor's degree required in a relevant science/engineering field.
• 10+ years in Sterility Assurance within pharma/biotech manufacturing.
• Experience driving EU Annex 1 compliance programs.

Responsabilidades

• Provide technical expertise on sterility assurance and EU Annex 1 compliance requirements.
• Conduct gap and risk assessments, contamination control reviews.
• Translate regulatory requirements into practical project solutions.
• Support development/review of project scopes, technical requirements, design criteria, and acceptance criteria.
• Evaluate engineering, facility, equipment, and process solutions from a sterility perspective.
• Support Contamination Control Strategy development and implementation.
• Participate in design reviews, vendor assessments, commissioning, qualification, and validation.
• Identify gaps and recommend remediation strategies.
• Collaborate with cross-functional stakeholders to enable project delivery.

Conhecimentos

Sterility Assurance

Aseptic Processing

GMP Manufacturing

Cleanroom Operations

Regulatory Compliance

Formação académica

Bachelor's degree in Engineering, Microbiology, Life Sciences, Pharmaceutical Sciences, Biotechnology, or related discipline

Descrição da oferta de emprego

i-Pharm GxP is seeking a Sterility Assurance Subject Matter Expert (SME) to support EU Annex 1 compliance and remediation programmes at a leading biopharmaceutical site in Illinois, USA. The role focuses on aseptic processing, contamination control, cleanroom operations, and Annex 1 implementation.

The SME will work with Quality, Engineering, Manufacturing, Validation, and Global Sterility Assurance teams to identify gaps, design remediation strategies, and drive compliant site improvements