Aseptic Equipment Lead; Weekend PM

About Simtra Bio Pharma Solutions

Simtra Bio Pharma Solutions (Simtra) is a world‑class contract development manufacturing organization (CDMO) partnering with pharmaceutical and biotech companies to bring sterile injectable products to market. With facilities in Bloomington, Indiana, United States and Halle/Westfalen, Germany, Simtra offers delivery systems including pre‑filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder‑filled vials, and sterile crystallization. Simtra is committed to quality, continuous improvement, and regulatory excellence.

Simtra embraces a growth mindset, cross‑team collaboration, high standards of excellence, and a day‑to‑day impact on patient health.

As an Aseptic Equipment Lead, you will 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. Working closely with Engineering, Maintenance, and Filling Operators, you will be the go‑to expert for the equipment in your area and a driving force behind continuous improvement.

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

• 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.

Fast‑paced, hands‑on sterile manufacturing environment. Grade A–D cleanroom spaces. 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.

Medical & Dental Coverage, Flexible Spending Accounts, Life and AD&D Insurance, Supplemental Life Insurance (Spouse, Child), Short‑Term and Long‑Term Disability 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, 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).

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.

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.