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Aseptic Cleanroom Subject Matter Expert
Job in
Wichita, Sedgwick County, Kansas, 67232, USA
Listed on 2026-07-14
Listing for:
Fagron Sterile Services US (FSS)
Full Time
position Listed on 2026-07-14
Job specializations:
-
Manufacturing / Production
Pharmaceutical Manufacturing, Validation Engineer, Regulatory Compliance Specialist, Quality Engineering
Job Description & How to Apply Below
The Aseptic Cleanroom SME serves as a technical authority for sterile manufacturing operations within a 503B outsourcing facility. This role provides hands‑on leadership in aseptic processing, cleanroom compliance, contamination control, and commercial manufacturing execution while partnering cross-functionally to ensure safe, compliant, and efficient production.
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; escalation 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
- 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
- Other duties as assigned
- Bachelor's degree (STEM discipline) OR 5+ years of 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
- Ability to manage multiple priorities in a fast-paced environment
- Aseptic Processing & Sterility Assurance
- Cleanroom Compliance & Contamination Control
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