Onsite Manufacturing Validation Engineer

Net2Source (N2S); Warsaw (IN); On-site; USD 100,289,000 - 114,616,000; Full time

Job summary

Net2Source Inc. is seeking a Validation Engineer for an onsite role in Warsaw, IN. The position supports process readiness, equipment qualification, and manufacturing system implementation to ensure compliant site operations.

Candidates should have strong Windchill knowledge, experience with Gage R&R, vault DMR updates, and ability to develop and maintain control plans and documentation. Responsibilities include reviewing NCRs/IEs/CAPAs, ECNs, BOM updates, supporting MES readiness, and

Qualifications

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

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 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 knowledge

Gage R&R experience

Cross-functional collaboration

Documentation & compliance

Education

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

Tools

Vault DMR system

InfoPV equipment qualification

Job description

Net2Source Inc. is seeking a Validation Engineer for an onsite role in Warsaw, IN. The position supports process readiness, equipment qualification, and manufacturing system implementation to ensure compliant site operations.

Candidates should have strong Windchill knowledge, experience with Gage R&R, vault DMR updates, and ability to develop and maintain control plans and documentation. Responsibilities include reviewing NCRs/IEs/CAPAs, ECNs, BOM updates, supporting MES readiness, and