Aseptic Equipment Lead — Manufacturing Ops

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) with Company Match

Paid Holidays

Paid Time Off

Parental Leave

Education Assistance

Employee Assistance Program

Onsite Campus Amenities

Job summary

Simtra BioPharma Solutions in Bloomington, IN is seeking an Equipment Coordination Supervisor to oversee daily equipment coordination in an aseptic manufacturing environment, reporting to the Senior Manager of Engineering and Maintenance.

The role focuses on GMP compliance, equipment lifecycle data in Dynamics 365, and collaboration with Technical Services to ensure readiness for new products, process changes, and projects.

Qualifications

• High school diploma or GED required.
• Associates degree preferred.
• 2+ years of industrial manufacturing, maintenance or engineering experience.
• 1+ year of leadership experience.
• Proficient with Microsoft Word, Excel, Outlook and enterprise software (e.g., JDE, BPLM, Dynamics, TrackWise).

Responsibilities

• Supervise daily equipment coordination to meet manufacturing goals while maintaining GMP compliance.
• Issue and track product-contact equipment for GMP and non-GMP batches and testing activities.
• Manage inventory for all product-contact equipment, monitor condition, coordinate repairs, and procure new parts.
• Maintain equipment lifecycle data and status updates in Microsoft Dynamics 365 with traceability.
• Serialize, passivate, and etch new equipment; enter asset data in Dynamics 365.
• Partner with Technical Services to ensure equipment availability for new products and process changes.
• Review manufacturing batch records and equipment project plans.
• Support change-control activities to align with quality standards and regulatory expectations.
• Participate in spare part analysis and inventory development.

Job description

Simtra BioPharma Solutions in Bloomington, IN is seeking an Equipment Coordination Supervisor to oversee daily equipment coordination in an aseptic manufacturing environment, reporting to the Senior Manager of Engineering and Maintenance.

The role focuses on GMP compliance, equipment lifecycle data in Dynamics 365, and collaboration with Technical Services to ensure readiness for new products, process changes, and projects.