We are hiring a Validation Engineer for our Client specializing in percutaneous interventional medical devices for the global market .

Role

The Validation Engineer generates manufacturing documentation, processing changes, supporting the Operation & Engineering staffs. The Validation Engineer work with other functional groups, such as Document control, Quality, Regulatory Affairs, Research & Development, supporting new product development.

Ensures required documentation for new materials is in place for initial builds and testing using the DCF process. Works on complex mechanical problems where analyzing situations or data requires an in-depth evaluation. Exercise judgment within defined practices and policies in selection methods, techniques, and evaluation criteria for obtaining results. Determines methods, processes and procedures on new assignments and may provide guidance to others.

As Validation Engineer, your main responsibilities are as follows:

Run process qualifications including Instillation Qualification, Operational Qualification and Performance / IQ OQ PQ
Develop, design and execute validation protocols
Review and approve design change control, validation protocols and reports
Coordinate and act as subject matter expert for schedule, execution of schedule, validation policy and practice
Write, review and approve validation change controls and validation protocols IQ OQ PQ PV standard operating procedures, CAPAs reports
Perform training to procedural and quality system changes
Facilitate Risk Management process in compliance to appropriate external standards and corporate policies
Drive Quality Engineering activities designed to improve customer satisfaction and achievement of company quality objectives
Has advanced knowledge in the areas of Validation, Design Controls, Risk Management and Statistical Techniques
Responsible for ensuring compliance with all company regulations, policies and procedures

Education / Experience Requirements

Minimum Bachelor Degree in Manufacturing / Mechanical engineering
3 - 5 years work experience exposure in process and/or manufacturing environment

Skills & Qualifications

Ability to perform root cause analysis for production issues
Attention to details
Able to conduct and interpret statistics
Good knowledge in Microsoft Office
Minitab will be an advantage
Ability to work in team
Good communication skills in both English & French, both written and verbal

Benefits:

Training plans
Medical Insurance
Team Building
Transport or Fuel allowance

Health & Medical jobs

Validation Engineer