Demo

Validation Engineer

Katalyst HealthCares and Life Sciences
Irvine, CA Full Time
POSTED ON 2/28/2025
AVAILABLE BEFORE 5/28/2025

Responsibilities :

  • In accordance with all applicable federal, state and local laws / regulations and Corporate Pharmaceutical, procedures and guidelines,
  • This position : Identifies, designs, and develops the necessary equipment related to new product Introduction.
  • Initiate Validation Master Plan for new projects.
  • Develop manufacturing process for new projects.
  • Perform IQ, OQ, PQ protocol writing and validation activities.
  • Guage R&R approach.
  • Studies the existing processes to implement improvements on new products.
  • Perform NPI prototyping, NPI project phase.
  • Responsible for preparing and managing specifications.? Performs activities of process / product validation.
  • Manage the projects by conducting meetings, tracking milestones, define project plan.
  • Responsible for communicating business related issues or opportunities to next management level.
  • Performs other duties assigned as needed.
  • Project Management experience.

Requirements :

  • Bachelor of Engineering, any specialty.
  • NPI Validation Engineer 3 years of medical device experience in NPI, Windchill PLM, under limited supervision, performs and documents moderately complex technical functions relating to test, quality control, Client-out, fabrication, modification, and assembly of mechanical or electrical equipment and / or components.
  • Experience in validation of product and equipment.
  • Experience in New Product Introduction (NPD) with SolidWorks.
  • Knowledge of good manufacturing practices and documentation, preferably in the medical industry.
  • Risk management experience pFMEA and dFMEA.
  • Knowledge on QMS - NC, CAPA and contribution in audits and ETQ instinct experience if any? Preferably with knowledge of ISO 13485, FDA 21 CFR Part 820 and GMP.
  • JnJ experience with ADAPTIV and Windchill PLM.
  • Oral and written communication in English.
  • NPI Validation experience, preferably knowledge in the medical industry.
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