Aseptic Equipment Lead: Optimize a Key Filling Line

Simtra US LLC; Bloomington (IN); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical & Dental Coverage

Flexible Spending Accounts

Life and AD&D Insurance

401(k) Retirement Savings Plan with 1:

Job summary

Simtra US LLC seeks an Aseptic Equipment Lead (AEL) to own the setup, performance, and optimization of a key aseptic filling line during your shift. You will collaborate closely with Engineering, Maintenance, and Filling Operators to ensure production success and product quality.

You will be the goto expert for the equipment, drive continuous improvement, and help maintain a fast-paced Grade A-D cleanroom environment with emphasis on safety and efficiency.

Qualifications

• High school diploma or GED required.
• At least 3 years of manufacturing experience.
• Proficiency in Microsoft Word, Excel and Outlook, with ability to learn ERP systems.
• Strong mechanical aptitude and hands-on troubleshooting in equipment-focused environments.

Responsibilities

• Become the subject-matter expert for the assigned filling line—whether syringe or vial equipment—and its supporting systems.
• Lead troubleshooting by investigating complex issues, identifying root causes, and implementing effective, long-term solutions.
• Monitor and evaluate line performance to support Out of Control Limit Reports (OCRs) and ensure inspection readiness.
• Analyze trends to uncover opportunities to reduce downtime, improve operator efficiency, and boost product yield.
• Standardize and train others on equipment setup and basic troubleshooting, ensuring operators and production leaders feel confident and capable.
• Partner with Line Engineers and Operational Excellence teams to champion improvements that enhance safety, quality, efficiency, and overall team performance.
• Maintain Grade A/B aseptic gowning certification and successfully complete operator qualification/media fill requirements.

Skills

Mechanical aptitude

Troubleshooting

Hands-on equipment experience

Microsoft Word

Microsoft Excel

Outlook

Veeva

D365

Blue Mountain

Education

High school diploma or GED

Tools

Microsoft Word

Microsoft Excel

Outlook

Veeva

D365

Blue Mountain

Job description

Simtra US LLC seeks an Aseptic Equipment Lead (AEL) to own the setup, performance, and optimization of a key aseptic filling line during your shift. You will collaborate closely with Engineering, Maintenance, and Filling Operators to ensure production success and product quality.

You will be the goto expert for the equipment, drive continuous improvement, and help maintain a fast-paced Grade A-D cleanroom environment with emphasis on safety and efficiency.