Aseptic Equipment Lead (Weekend PM)
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Before you apply
LocationBloomington, IN, Bloomington, Indiana, United States
Work modeon-site
Typefull-time
SeniorityLead
Experience3+ yrs
DepartmentPlant Operations
EquityIncluded
Company size1,001–5,000 people
PostedFeb 17, 2026 · 8mo ago
Verified live13h ago
May no longer be actively hiring
Posted by the company on Feb 17, 2026
At a glanceSummarised by Seekless from the posting.
High school diploma or GED
At least 3 years of manufacturing experience
Proficiency in Microsoft Word, Excel, and Outlook
Ability to learn enterprise systems such as Veeva, D365, and Blue Mountain
Strong mechanical aptitude and ability to troubleshoot in a hands-on equipment-focused environment
Become the subject-matter expert for assigned filling line and supporting systems
Lead troubleshooting efforts, investigate complex issues, identify root causes, implement long-term solutions
Monitor and evaluate line performance to support OCRs and inspection readiness
Analyze trends to reduce downtime, improve operator efficiency, boost product yield
Standardize and train others on equipment setup and basic troubleshooting
Partner with Line Engineers and Operational Excellence teams to champion improvements
Maintain Grade A/B aseptic gowning certification and complete operator qualification/media fill 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
Skills
Microsoft Word
Microsoft Excel
Microsoft Outlook
Veeva
D365
Blue Mountain
Benefits
Medical insurance
Dental insurance
Flexible spending accounts
Life insurance
Supplemental life insurance
Spouse life insurance
Child life insurance
401(k)
Paid time off
Paid holidays
Paid parental leave
Adoption reimbursement
Education assistance
Employee assistance program
Commuter benefits
Employee ownership plan
Short term disability insurance
Long term disability insurance
Vision coverage
Accident insurance
Critical illness insurance
Hospital indemnity insurance
Identity theft protection
Legal insurance
Onsite workout facility
Onsite cafeteria
Onsite credit union
About the company
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.
•
Work in Grade A–D controlled environments for long durations.
•
Frequent use of hands and fingers for precise equipment manipulation.
Benefits
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.
Data Privacy
To learn more about Simtra’s approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/