Manufacturing Engineer

Job Description

Job Description

Title: Manufacturing Engineer

Location: Warsaw, IN

Contract: 08/31/2026 to 08/27/2027

Position summary

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.

Skills:    

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.

Education:

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.

Strong control plan knowledge.

Experience with Vault DMR updates and controlled document maintenance.

Experience with process changes, documentation, and cross-functional implementation.

Fusion was founded to set a new standard in Health care consulting and staffing Industry. Our company is made up of Technical experts, dreamers, calculated risk-takers, diligent people that go to fight for the brand of our client. We offer Engineering and FDA remediation services for the Pharmaceutical, Bulk Drug Manufacturing, Biotechnology, Medical Device and Heath Diagnostic industries. Fusion was founded on the promise that we would provide a superior staffing experience for our clients by delivering the highest trained individuals.

Fusion provide innovative talent solutions that make our clients businesses better. Our verticals include Healthcare and FDA Remediation.

We exist to become the finest and most esteemed staffing company across USA, and we look forward to putting our talents to use to push your organization forward.

Company Description

Fusion was founded to set a new standard in Health care consulting and staffing Industry. Our company is made up of Technical experts, dreamers, calculated risk-takers, diligent people that go to fight for the brand of our client. We offer Engineering and FDA remediation services for the Pharmaceutical, Bulk Drug Manufacturing, Biotechnology, Medical Device and Heath Diagnostic industries. Fusion was founded on the promise that we would provide a superior staffing experience for our clients by delivering the highest trained individuals.\r\n\r\nFusion provide innovative talent solutions that make our clients businesses better. Our verticals include Healthcare and FDA Remediation.\r\n\r\nWe exist to become the finest and most esteemed staffing company across USA, and we look forward to putting our talents to use to push your organization forward.