Aseptic Equipment Lead
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Upload Your ResumeAbout This Role
This role involves leading the setup, performance, and optimization of aseptic filling lines within a sterile manufacturing environment. The Aseptic Equipment Lead will be the go-to expert for equipment, driving continuous improvement in production success, product quality, and team efficiency.
Responsibilities
- Become the subject-matter expert for assigned filling lines and supporting systems (component washers, tunnels, filling/stoppering machines, cappers, tray loaders, 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
- 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
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 such as Veeva, D365, and Blue Mountain
- Strong mechanical aptitude and the ability to troubleshoot in a hands-on, equipment-focused environment
Qualifications
- High school diploma or GED
- At least 3 years of manufacturing experience
Skills
* Required skills
Benefits
About Simtra BioPharma Solutions
Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market.