Assist with protocol creation, execution support, and report activities tied to manufacturing changes and product transfers. Support equipment installation, qualification, validation, and decommissioning activities as needed at both the client sites and transfer supplier sites.
Numbers & Facts
Location
Parsippany, NJ
Salary
$35.87–$39.38 Per Hour
Description
Our Client, a Medical Devices/Healthcare company, is looking for a Manufacturing Engineer (Transfers) for their Parsippany, NJ location.
Responsibilities:
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 as needed at both the client sites and transfer supplier sites.
Assist with protocol creation, execution support, and report activities tied to manufacturing changes and product transfers.
Support transfer documentation forms.
Use Windchill to review, manage, and support engineering documentation and change activity.
Develop, review, and maintain SOPs to ensure manufacturing process consistency and compliance at various sites within the transfer scope.
Maintain accuracy of controlled manufacturing records and related documentation.
Partner with Transfer, Operations and Quality to improve flow, efficiency, and manufacturability.
Requirements:
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 controlled document maintenance.
Experience with process changes, documentation, and cross-functional implementation.