Onsite Warsaw Manufacturing Engineer — Process Readiness & Change

Actalent; Warszawa; On-site; PLN 196,000 - 228,000; Full time

Job summary

Actalent is seeking a Manufacturing Engineer for an onsite role in Warsaw. You will support process readiness, equipment qualification/validation, and manufacturing system implementation while maintaining critical documentation in Windchill and Vault DMR.

The position involves review and creation of ECRs/ECNs, BOM updates, and work instructions. The ideal candidate has a Bachelor’s degree in a relevant engineering field plus experience in a regulated production setting, with strong knowledge of

Qualifications

• Requires a Bachelor’s degree in Mechanical, Manufacturing, Industrial, or related engineering field.
• Experience in manufacturing engineering in a regulated production setting.
• Strong Windchill knowledge and familiarity with equipment qualification/validation documentation.
• Working knowledge of control plans and documentation practices.
• 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 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 maintain accuracy of controlled manufacturing records and related documentation.
• Apply methods to evaluate measurement system capability and support process controls.
• Develop, review, and maintain control plans to ensure manufacturing process consistency and compliance.
• Partner with Operations and Quality to improve flow, efficiency, and manufacturability.

Skills

Windchill

Equipment qualification

Control plans

Vault DMR

Process changes

Education

Bachelor's degree in Mechanical/Manufacturing/Industrial engineering or related field

Tools

Windchill

Vault DMR

Job description

Actalent is seeking a Manufacturing Engineer for an onsite role in Warsaw. You will support process readiness, equipment qualification/validation, and manufacturing system implementation while maintaining critical documentation in Windchill and Vault DMR.

The position involves review and creation of ECRs/ECNs, BOM updates, and work instructions. The ideal candidate has a Bachelor’s degree in a relevant engineering field plus experience in a regulated production setting, with strong knowledge of