Aseptic Equipment Lead (2nd Shift)

Simtra BioPharma Solutions•Bloomington, IN

5d•Onsite

About The Position

As an Aseptic Equipment Lead (AEL), you’ll be at the heart of our sterile manufacturing operations. You’ll own the setup, performance, and optimization of a key aseptic filling line during your shift—making a direct impact on production success, product quality, and team efficiency. Working closely with Engineering, Maintenance, and Filling Operators, you’ll be the go‑to expert for the equipment in your area and a driving force behind continuous improvement.

Requirements

High school diploma or GED.
At least 3 years of manufacturing experience.
Proficiency in Microsoft Word, Excel, and Outlook, plus the ability to learn enterprise systems such as Veeva, D365, and Blue Mountain.
Strong mechanical aptitude and the ability to troubleshoot in a hands‑on, equipment‑focused environment.
Ability to lift up to 50 lbs.
Ability to stand and/or walk for extended periods.
Work in Grade A–D controlled environments for long durations.
Frequent use of hands and fingers for precise equipment manipulation.

Responsibilities

Become the subject‑matter expert for your assigned filling line—whether syringe or vial equipment—and its supporting systems such as component washers, depyrogenation tunnels, filling and stoppering machines, cappers, tray loaders, and lyophilizer loading/unloading systems.
Lead troubleshooting efforts 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.