Sterility Assurance Subject Matter Expert; SME
Job in
Elgin, Kane County, Illinois, 60120, USA
Listed on 2026-10-30
Listing for:
i-Pharm GxP
Full Time
position Listed on 2026-10-30
Job specializations:
-
Pharmaceutical
Pharma Engineer, Pharmaceutical Manufacturing, Quality Engineering, Validation Engineer -
Engineering
Pharma Engineer, Quality Engineering, Validation Engineer
Job Description & How to Apply Below
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.
- 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.
- EU Annex 1 Compliance
- Aseptic Processing
- Container Closure Integrity Testing (CCIT)
- PUPSIT & Sterile Filtration
- Cleanroom & HVAC Improvements
- Facility & Process Upgrades
- Manufacturing Compliance Initiatives
- 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.
- 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.
- Hands-on experience with CCIT, PUPSIT, isolators, sterile filtration, and aseptic filling operations.
- Experience supporting CAPEX projects or facility upgrade programmes.
- Biopharmaceutical manufacturing experience.
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