Manufacturing Engineer Job at cGxPServe, Indianapolis, IN

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  • cGxPServe
  • Indianapolis, IN

Job Description

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.

Job Tags

Immediate start,

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