Aseptic Equipment Lead

Responsibilities

• Act as the subject-matter expert for assigned filling lines and supporting systems including component washers, depyrogenation tunnels, and filling machines
• Lead troubleshooting efforts by investigating complex issues and implementing long-term solutions
• Monitor line performance to support Out of Control Limit Reports (OCRs) and ensure inspection readiness
• Analyze trends to reduce downtime, improve operator efficiency, and boost product yield
• Standardize and train personnel on equipment setup and basic troubleshooting
• Partner with Engineering and Operational Excellence teams to champion safety, quality, and efficiency improvements
• Maintain Grade A/B aseptic gowning certification and complete operator qualification requirements

Requirements

• High school diploma or GED
• At least 3 years of manufacturing experience
• Proficiency in Microsoft Word, Excel, and Outlook
• Ability to learn enterprise systems like Veeva, D365, and Blue Mountain
• Strong mechanical aptitude for hands-on troubleshooting
• Ability to lift up to 50 lbs and stand/walk for extended periods
• Ability to work in Grade A–D controlled cleanroom environments

About the Company

Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization (CDMO) that partners with pharmaceutical and biotech companies to bring sterile injectable products to market, including biologics, small molecules, and vaccines.