Manufacturing Engineer

cGxPServe • Full-time • Zionsville, IN, US • 1m ago

Job Description

We are urgently hiring three Manufacturing Engineers with strong experience in medical device manufacturing and remediation.
These roles will focus on remediation activities, process optimization, and ensuring compliance with regulatory standards.
The ideal candidates will bring expertise in validation, CAPA, and risk management, while working cross-functionally to resolve compliance gaps and strengthen manufacturing operations.

Roles & Responsibilities:

Remediation Initiatives.
Lead remediation projects by identifying and addressing root causes of product or process deficiencies.
Develop and implement Corrective and Preventive Actions (CAPAs) and remediation action plans.
Conduct gap analyses of processes, documentation, and equipment to ensure compliance.
Manufacturing Process Engineering.
Design, implement, and optimize manufacturing processes to improve efficiency, quality, and compliance.
Apply Design for Manufacturability (DFM) principles to reduce risks and streamline production.
Troubleshoot and resolve production issues with robust, sustainable solutions.
Quality & Validation.
Support process and product validation activities, including IQ/OQ/PQ and test method validation.
Perform and document risk assessments (FMEA, PFMEA).
Ensure remediation actions are verified and documented in line with QMS and regulatory standards.

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