Aseptic Equipment Lead (Weekend PM)
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Job Location:
Bloomington, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
15 hours ago
Vacancies:
1 Vacancy
Job Summary
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 teamsso we can solve problems in new ways.
Make it RIGHT We hold ourselves to a high standard of excellencefulfilling 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) youll be at the heart of our sterile manufacturing operations. Youll own the setup performance and optimization of a key aseptic filling line during your shiftmaking a direct impact on production success product quality and team efficiency. Working closely with Engineering Maintenance and Filling Operators youll be the goto expert for the equipment in your area and a driving force behind continuous improvement.
Schedule: 7pm-7:30am (Friday - Monday)
The responsibilities:
- Become the subjectmatter expert for your assigned filling linewhether syringe or vial equipmentand 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:
Youll work in a fastpaced handson sterile manufacturing environment with direct interaction with complex automated equipment. Time is spent within Grade AD 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 AD controlled environments for long durations.
- Frequent use of hands and fingers for precise equipment manipulation.
In return youll be eligible for1:
- Day One 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
- Additional Benefits
- 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
- Voluntary Insurance Benefits
1 Current benefit offerings are in effect through 12/31/25
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 Simtras approach to data privacy please review the Simtra Recruitment Platform Global Privacy Policy:
Key Skills
- New Equipment
- Equipment Performance
- Parts Inventory
- personal protective
- Semiconductor
- Project Management
- Process Control
- Equipment Design
- Equipment Issues
- Equipments inspection
- Mechanical Equipment
- Maintenance Activities
- Visual Inspections
- Data Analysis
- Air Compressors
About Company
THIS IS WHERE IT ALL BEGAN Did you know that Baxter is the first commercial manufacturer of prepared IV solutions? It all started in 1931 in Iowa when Dr. Ralph Falk and Dr. Donald Baxter launched the Don Baxter Intravenous Products Company. Hillrom’s roots go back to when Bill Hille ... View more
