Aseptic Cleanroom Subject Matter Expert

Key Responsibilities

• Serve as SME for aseptic processing and contamination control strategies
• Maintain gowning qualification; operate in ISO-classified environments
• Support compounding, filtration, filling, sterilization, and component prep
• Ensure cleanroom and equipment compliance with cGMP and regulatory standards
• Partner with leadership to ensure efficient, compliant production operations
• Troubleshoot equipment and process issues; escalate as needed
• Support equipment selection, layout, and optimization
• Lead or support: Deviations, CAPAs, commitments, Change controls (DCEs), SOP authoring and revisions, Interpret and enforce cGMP and internal policies, Identify risks and implement corrective actions, Train and qualify personnel in aseptic technique and cleanroom behavior, Ensure training compliance and readiness, Provide mentorship and input to staffing plans, Lead continuous improvement initiatives (efficiency, yield, compliance), Analyze performance metrics and recommend improvements, Support commercialization and scaling of operations, Act as liaison across Manufacturing, QA, Engineering, and Supply Chain, Support technology transfer and new product introduction, Drive alignment on production and quality goals, Maintain raw material and component inventory systems, Train staff on ERP/inventory tools

Basic Qualifications

• Bachelor's degree (STEM discipline) OR 5+ years sterile pharmaceutical manufacturing (injectables / 503B preferred)
• Strong knowledge of cGMP, USP / (preferred), and aseptic processing
• Experience in ISO 5/7/8 cleanroom environments
• Demonstrated experience with deviations, CAPA, and SOP lifecycle
• Able to manage multiple priorities in a fast-paced environment
• Aseptic Processing & Sterility Assurance
• Cleanroom Compliance & Contamination Control
• Quality Systems & Regulatory Knowledge
• Technical Leadership & Mentorship
• Problem Solving & Troubleshooting
• Continuous Improvement Mindset