Aseptic Equipment Lead

Responsibilities

• Act as the subject-matter expert for assigned filling lines and supporting systems
• Lead troubleshooting efforts by investigating complex issues and implementing long-term solutions
• Monitor and evaluate line performance to support Out of Control Limit Reports (OCRs)
• Analyze trends to reduce downtime and improve operator efficiency and product yield
• Standardize and train others on equipment setup and basic troubleshooting
• Partner with Line Engineers and Operational Excellence teams to champion 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 environments

About the Company

Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring sterile injectable products to market.