Aseptic Equipment Lead - Drive Line Performance & Quality

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 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.