What are the responsibilities and job description for the Aseptic Cleanroom Subject Matter Expert position at Fagron?
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
Bachelor’s degree (STEM discipline) OR 5 years sterile pharmaceutical manufacturing (injectables / 503B preferred) Strong knowledge of cGMP, USP / (preferred), and aseptic processingExperience 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.
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
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.