Aseptic Equipment Lead (2nd Shift)

Simtra US LLC; Bloomington (IN); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical & Dental Coverage

Flexible Spending Accounts

Life and AD&D Insurance

401(k) Retirement Savings Plan with 1:

Job summary

Simtra US LLC seeks an Aseptic Equipment Lead (AEL) to own the setup, performance, and optimization of a key aseptic filling line during your shift. You will collaborate closely with Engineering, Maintenance, and Filling Operators to ensure production success and product quality.

You will be the goto expert for the equipment, drive continuous improvement, and help maintain a fast-paced Grade A-D cleanroom environment with emphasis on safety and efficiency.

Qualifications

• High school diploma or GED required.
• At least 3 years of manufacturing experience.
• Proficiency in Microsoft Word, Excel and Outlook, with ability to learn ERP systems.
• Strong mechanical aptitude and hands-on troubleshooting in equipment-focused environments.

Responsibilities

• Become the subject-matter expert for the assigned filling line—whether syringe or vial equipment—and its supporting systems.
• Lead troubleshooting 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.

Skills

Mechanical aptitude

Troubleshooting

Hands-on equipment experience

Microsoft Word

Microsoft Excel

Outlook

Veeva

D365

Blue Mountain

Education

High school diploma or GED

Tools

Microsoft Word

Microsoft Excel

Outlook

Veeva

D365

Blue Mountain

Job description

Why join Team Simtra?

Because we:

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 - taking on challenges big and small to improve patient health.

This role:

As an Aseptic Equipment Lead (AEL), you'll be at the heart of our sterile manufacturing operations. You'll 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. Working closely with Engineering, Maintenance, and Filling Operators, you'll be the goto expert for the equipment in your area and a driving force behind continuous improvement.

Schedule

2pm - 12:30am (Monday- Thursday)

The responsibilities:

• Become the subjectmatter 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, longterm 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 fastpaced, handson sterile manufacturing environment with direct interaction with complex automated equipment. Time is spent within Grade A-D cleanroom spaces, supporting the critical production of highquality sterile products.

Required qualifications:

• 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 handson, equipmentfocused 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] :

• 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
  • Short and Long-Term Disability Insurance
• 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

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

Disclaimer

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.

Equal Employment Opportunity

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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