Aseptic Equipment Lead; 1st Shift

Overview

Simtra Bio Pharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines, which are all directly injected into patients worldwide.

There is a strong emphasis on quality and continuous improvement at Simtra, with a focus on high quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

• Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
• Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams so we can solve problems in new ways.
• Make it RIGHT - We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.
• Make it COUNT - We take pride in our day-to-day work, knowing the impact we make to improve patient health.

As an Aseptic Equipment Lead (AEL), you'll be at the heart of our sterile manufacturing operations. You will 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. You will work closely with Engineering, Maintenance, and Filling Operators, serving as the go-to expert for the equipment in your area and driving continuous improvement.

Schedule: 6am - 4:30pm (Monday - Thursday)

• Become the subject-matter expert for your assigned filling line (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.

You'll work in a fast-paced, hands-on sterile manufacturing environment with direct interaction with complex automated equipment. Time is spent within Grade A-D cleanroom spaces, supporting the critical production of high-quality sterile products.

• 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.

[1]:
Current benefit offerings are in effect through 12/31/26

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

Disclaimer:
Current benefit offerings are in effect through 12/31/26.

This job description is intended to provide the minimum knowledge, skills and abilities necessary to…