Katalyst CRO

Validation Engineer

5 months ago

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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.