Aseptic Equipment Lead (3rd Shift)

The responsibilities:

• Become the subject‐matter expert for your assigned filling line—whether 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.

The work environment:

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.

Physical / safety requirements:

• 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.

In return, you’ll be eligible for [1]:

• Life and AD&D Insurance

• 401(k) Retirement Savings Plan with Company Match

• Paid Holidays

• Paid Parental Leave and more

• Community and Volunteer Service Program

• Additional Benefits
• Short and Long-Term Disability Insurance

• Vision Coverage
• Accident
• Critical Illness

• Legal and more

• Workout Facility
• Cafeteria
• Credit Union

[1] 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 perform the job.

It may not be inclusive of all the duties and responsibilities of the job.

Simtra reserves the right to make modifications based on business requirements.

Simtra is proud to be an equal opportunity employer.

Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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