Manufacturing Engineer - Process Readiness & Change

Fusion Life Sciences Technologies LLC; Warsaw (IN); On-site; USD 70,000 - 98,000; Full time

Job summary

Fusion Life Sciences Technologies LLC is seeking a Manufacturing Engineer to support process readiness, changes, equipment activities, and documentation for efficient site operations. The role requires Windchill expertise, equipment qualification, Gage R&R experience, and vault DMR updates to maintain compliant manufacturing records.

Responsibilities include reviewing NCRs/IEs/CAPAs, ECRs/ECNs, BOM updates, and work instructions, plus MES readiness and master data activities.

Qualifications

• Bachelor’s degree in Mechanical, Manufacturing, Industrial, or related engineering field.
• Experience in manufacturing engineering in a regulated production setting.
• Strong Windchill knowledge.
• Working knowledge of equipment qualification/validation processes and documentation.
• Experience with Gage R&R studies and interpretation.
• Experience with Vault DMR updates and controlled document maintenance.
• Experience with process changes, documentation, and cross-functional implementation.

Responsibilities

• Support site Quality records such as NCRs, IE’s, and CAPA’s.
• Own and Review ECRs, ECNs, routers, BOM updates, and work instructions.
• Walk processes to assess readiness, risks, and implementation needs.
• Support equipment installation, qualification, validation, and decommissioning activities.
• Assist with protocol creation, execution support, and report activities tied to manufacturing changes.
• Support MES readiness and manufacturing master data activities.
• Use Windchill to review, manage, and support engineering documentation and change activity.
• Support InfoPV equipment qualification activities, including documentation, execution support, and traceability.
• Apply Gage R&R methods to evaluate measurement system capability and support process controls.
• Develop, review, and maintain control plans to ensure manufacturing process consistency and compliance.
• Support Vault DMR updates and maintain accuracy of controlled manufacturing records and related documentation.
• Partner with Operations and Quality to improve flow, efficiency, and manufacturability.

Skills

Windchill

Gage R&R

Control plans

NCRs/IEs/CAPAs handling

Education

Bachelor’s degree in Mechanical, Manufacturing, Industrial, or related engineering field

3+ Years experience in manufacturing engineering

Tools

Vault DMR

InfoPV equipment

Job description

Fusion Life Sciences Technologies LLC is seeking a Manufacturing Engineer to support process readiness, changes, equipment activities, and documentation for efficient site operations. The role requires Windchill expertise, equipment qualification, Gage R&R experience, and vault DMR updates to maintain compliant manufacturing records.

Responsibilities include reviewing NCRs/IEs/CAPAs, ECRs/ECNs, BOM updates, and work instructions, plus MES readiness and master data activities.