Manufacturing Engineer - medical device, pharmaceutical, biotech EXP

JOB DESCRIPTION:

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.

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