Aseptic Cleanroom Subject Matter Expert

Aseptic Cleanroom Subject Matter Expert Fagron - 2.6 Wichita, KS Job Details 16 hours ago Benefits Health savings account Paid holidays Health insurance Dental insurance 401(k) Paid time off Vision insurance 401(k) matching Qualifications Quality control corrective actions ISO standards Contamination control Production deviation management Corrective and preventive actions (CAPA) Equipment malfunction troubleshooting Cleanroom protocols Manufacturing standard operating procedures Quality assurance within pharmaceutical industry Mentoring Sterile processing regulatory compliance Regulatory/legal compliance standards in production Sterile attire donning Cleanroom Technical troubleshooting support Sterile medication handling Process improvement planning Standard operating procedures (SOPs) Healthcare compliance Full Job Description Who We Are Since 1990, we've grown into a global leader in personalized medicine. Today, our +5,000 energetic employees are based in +80 locations in Europe, North America, South America, Africa and Asia-Pacific and are working together to support over 200,000 customers worldwide. From compounding and natural products to software, equipment, and genomics — we deliver smart, ready-to-use solutions that make healthcare better. We're passionate, science-driven, and always looking for new ways to improve lives. Explore your future at Fagron Career Site. About the Job 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; 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 Other duties as assigned Basic Qualifications Bachelor's degree (STEM discipline) OR 5+ years sterile pharmaceutical manufacturing (injectables / 503B preferred) Strong knowledge of c

GMP, 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 Quality Systems & Regulatory Knowledge Technical Leadership & Mentorship Problem Solving & Troubleshooting Continuous Improvement Mindset What's on Offer? Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off. At Fagron, you'll find plenty of chances to grow — both personally and professionally. We work in an open, dynamic environment where your ideas and talents can shine. Ready for the challenge? We're proud to be an equal opportunity employer. Diversity makes us stronger, and we're committed to creating an inclusive workplace where everyone feels welcome. Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.

Job Reference:

NA00447