Sterility Assurance Subject Matter Expert (SME)

i-Pharm GxP; Illinois; On-site; USD 170,000 - 230,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Sterility Assurance

Aseptic Processing

GMP Manufacturing

Cleanroom Operations

Regulatory Compliance

Education

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

Job description

Job Title: Sterility Assurance Subject Matter Expert (SME)

Location: Illinois, USA (Fully On-Site)

Contract: Initial 12-Month Contract

We are seeking an experienced Sterility Assurance Subject Matter Expert (SME) to support a major EU Annex 1 compliance and remediation programme at a leading biopharmaceutical manufacturing site.

This is a high-impact role for a sterility assurance professional with strong expertise in aseptic processing, contamination control, cleanroom operations, and Annex 1 implementation. You'll work alongside Quality, Engineering, Manufacturing, Validation, and Global Sterility Assurance teams to support critical site improvements and ensure compliance across a broad portfolio of projects.

Key Responsibilities:

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

Key Project Areas:

• EU Annex 1 Compliance
• Aseptic Processing
• Container Closure Integrity Testing (CCIT)
• PUPSIT & Sterile Filtration
• Cleanroom & HVAC Improvements
• Facility & Process Upgrades
• Manufacturing Compliance Initiatives

Requirements:

• Bachelor's degree in Engineering, Microbiology, Life Sciences, Pharmaceutical Sciences, Biotechnology, or a related discipline.
• 10+ years' experience in Sterility Assurance within pharmaceutical, biotechnology, biologics, or vaccine manufacturing.

Strong knowledge of:

• EU Annex 1
• Aseptic Processing
• GMP Manufacturing
• Cleanroom Operations
• Experience supporting risk assessments, qualification, validation, and compliance improvement programmes.
• Proven ability to work effectively across Quality, Engineering, Manufacturing, and Validation functions.
• Excellent communication and stakeholder management skills.

Preferred Experience:

• Hands-on experience with CCIT, PUPSIT, isolators, sterile filtration, and aseptic filling operations.
• Experience supporting CAPEX projects or facility upgrade programmes.
• Biopharmaceutical manufacturing experience.