Simtra BioPharma Solutions · 5 hours ago
Aseptic Equipment Lead (1st Shift)
Bloomington, IN
Full-time
Onsite
Mid Level
3+ years expSimtra BioPharma Solutions is a leading Contract Development Manufacturing Organization that partners with pharmaceutical and biotech companies to deliver sterile injectable products. The Aseptic Equipment Lead will oversee the setup and optimization of aseptic filling lines, ensuring high production quality and team efficiency while collaborating with engineering and maintenance teams.
BiopharmaManufacturingMedicalPharmaceutical
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
Qualification
Required
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
Benefits
Medical & Dental Coverage
Flexible Spending Accounts
Life and AD&D Insurance
Supplemental Life Insurance
Spouse Life Insurance
Child Life Insurance
Short 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
Company
Simtra BioPharma Solutions
Simtra BioPharma Solutions is a pharmaceutical company that manufactures injectables and clinical supplies.
1001-5000 employees
H1B Sponsorship
Simtra BioPharma Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (5)
Funding
Current Stage
Late StageTotal Funding
$0.5M2024-12-19Grant· $0.5M
Leadership Team
M
Mike Schaefers
Chief Commercial Officer (CCO) & Head of Business Development
Recent News
2026-01-22
2026-01-20
Company data provided by crunchbase