Manufacturing Engineer

Aequor; Warsaw (IN); On-site; USD 65,000 - 95,000; Full time

Job summary

Aequor is seeking a Manufacturing Engineer in Indiana to support process readiness, engineering changes, equipment activities, and work instruction development. The role emphasizes Windchill knowledge, equipment qualification, Gage R&R, and Vault DMR documentation to ensure compliant site operations.

The engineer will review ECRs/ECNs, support MES readiness, and collaborate with Operations and Quality to improve manufacturability and efficiency at the site.

Qualifications

• Bachelor's degree in engineering or related field.
• A background in manufacturing engineering within a regulated production setting.
• Strong Windchill knowledge.
• Experience with 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 and cross-functional implementation.

Responsibilities

• Support site Quality records such as NCRs, IE's, and CAPAs.
• 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 reporting 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 Vault DMR updates and document traceability.
• Apply Gage R&R methods to evaluate measurement system capability and support process controls.
• Develop, review, and maintain control plans to ensure process consistency and compliance.
• Partner with Operations and Quality to improve flow and manufacturability.

Skills

Gage R&R

Control plans

Process changes

Education

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

Tools

Windchill

Vault DMR

Job description

The Manufacturing Engineer supports process readiness, engineering changes, equipment activities, work instruction development, and manufacturing system implementation to ensure efficient and compliant site operations. This role requires strong Windchill knowledge, Equipment qualification/validation knowledge, Gage R&R experience, control plan knowledge, and Vault DMR update knowledge to support documentation accuracy, qualification activities, manufacturing controls, and design/manufacturing change execution.

Key Responsibilities

• Support site Quality records such as NCR's, 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.

Required 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.