Aseptic Equipment Lead

Full Time Mid Level 3+ years

Posted 1 month ago Expired

This job has expired

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About 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

Microsoft Excel * Microsoft Outlook * Microsoft Word * Troubleshooting * D365 * Veeva * Blue Mountain *

* Required skills

Benefits

Paid Time Off
Child Life Insurance
Dental coverage
Critical illness insurance
Identity Theft Protection
401(k) Retirement Savings Plan with Company Match
Employee Ownership Plan
Onsite Workout Facility
Paid Holidays
Flexible spending accounts
Medical coverage
Employee Assistance Program
Life and AD&D Insurance
Education Assistance Program
Adoption Reimbursement Program
Voluntary Insurance Benefits
Onsite Credit Union
Paid parental leave
Accident insurance
Vision coverage
Hospital indemnity insurance
Supplemental life insurance
Legal services
Spouse Life Insurance
Community and Volunteer Service Program
Onsite Cafeteria

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.

Manufacturing
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