Aseptic Equipment Lead (Weekend PM)

Simtrabps; Bloomington (IN); On-site; USD 50,000 - 70,000; Full time

Job summary

Simtrabps is seeking an Aseptic Equipment Lead (AEL) in Bloomington, Indiana, responsible for maximizing the performance of aseptic filling lines. The AEL will be crucial in ensuring product quality and operational efficiency while working closely with cross-functional teams.

This role requires a high school diploma and at least 3 years of manufacturing experience, with a strong emphasis on troubleshooting skills and mechanical aptitude. The successful candidate will thrive in a fast-paced, hands-on sterile manufacturing environment.

Qualifications

• At least 3 years of manufacturing experience.
• Proficiency in enterprise systems like Veeva, D365, and Blue Mountain.

Responsibilities

• Own the setup, performance, and optimization of a key aseptic filling line.
• Lead troubleshooting efforts for the filling line equipment.
• Monitor and evaluate line performance for inspection readiness.
• Analyze trends to reduce downtime and improve efficiency.
• Standardize equipment setup and basic troubleshooting training.

Skills

Mechanical aptitude

Troubleshooting skills

Proficiency in Microsoft Word

Proficiency in Microsoft Excel

Proficiency in Microsoft Outlook

Education

High school diploma or GED

Tools

Veeva

D365

Blue Mountain

Job description

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. 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. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest 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.

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 go‑to expert for the equipment in your area and a driving force behind continuous improvement.

Schedule: 7pm-7:30am (Friday - Monday)

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.

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 hands‑on, equipment‑focused environment.

Physical / safety requirements

• Ability to lift up to 50 lbs.
• Ability to stand and/or walk for extended periods.