Aseptic Equipment Lead (1st Shift)

Simtra US LLC; Bloomington (IN); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with 2%

Paid Holidays

Paid Time Off

Paid Parental Leave

Adoption Reimbursement Program

Education Assistance Program

Employee Assistance Program

Job summary

Simtra BioPharma Solutions (Simtra) is seeking an Aseptic Equipment Lead to own the setup, performance, and optimization of a filling line during shifts. You will work with engineering, maintenance and operators to drive continuous improvement in production, quality, and efficiency in a highly controlled cleanroom environment.

The role requires hands-on technical skills, 3+ years manufacturing experience, and the ability to learn ERP systems such as Veeva, D365, and Blue Mountain.

Qualifications

• High school diploma or GED is required.
• At least 3 years of manufacturing experience.
• Strong mechanical aptitude and troubleshooting ability.
• Proficiency with MS Word, Excel, Outlook; able to learn ERP systems.

Responsibilities

• Become the subject-matter expert for your filling line and its support systems (washers, tunnels, cappers, lyophilizer loads).
• Lead troubleshooting by identifying root causes and implementing long-term solutions.
• Monitor line performance and support OCRs and inspection readiness.
• Analyze trends to reduce downtime, improve operator efficiency, and boost yield.
• Standardize equipment setup and train operators and leaders.
• Collaborate with Line Engineers and Operational Excellence to drive safety and quality improvements.
• Maintain aseptic gowning certification and complete qualification/media fill requirements.

Skills

Strong mechanical aptitude

Troubleshooting

Hands-on equipment focus

MS Office proficiency

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 goto expert for the equipment in your area and a driving force behind continuous improvement.

Schedule: 6am - 4:30pm (Monday - Thursday)

responsibilities:

• Become the subjectmatter 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, 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:

You’ll work in a fastpaced, handson sterile manufacturing environment with direct interaction with complex automated equipment. Time is spent within Grade A-D 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 A-D controlled environments for long durations.
• Frequent use of hands and fingers for precise equipment manipulation.

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.

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