Validation Engineer

Job Description:

Our client is looking for a Validation Engineer to support the development and testing of specific Manufacturing Systems for product and process quality  enhancements, technical alternatives, designs, standards, tests and validation documentation under low  level of supervision.

In this role you will work on:

• Creation of quality documents: Test Plan, Test Report, deviations.
• QA review of pre-executed and post-executed tests (Installation Verification, Installation Operational  Qualification, Data Migration, Integration Test, Configuration Test, Functional Test, User Acceptance  Test), regarding compliance with internal procedures and approved validation standards. 
• Participation in the development / improvement of QMS procedures and practices for data integrity /  CSV as it relates to the area of responsibility. 
• Coordination of validation activities during project or run and support. 
• CSV support for several affiliates in different time zones. 
• Advise Validation Lead, Project manager and Service Manager for validation activities and workload to  ensure proper planning and workforce mobilization to carry out the activities. 
• Train and coach on validation, practices related to CSV. Advise the business system owner on the fit for  purpose of the system and provide input to release the system for use by the business.

Requirements:

• University degree in technology, science, engineering or equivalent.  
• Substantial experience in computerized system validation area or validation activities (CSV/GAMP).  
• Sound expertise interacting with external suppliers and third parties.   
• Fluent in written and spoken English. 
• Good communicator that can work independently.
• The candidate must have an understanding of quality management (basics)
• Understanding of non conformity and deviations (client have guidelines so implementation will be ensured) 
• Knowledge of GAMP 5, V model and GxP (Good x Practices)

Optional requirements:

• JIRA and Confluence experience is an advantage (large part of the documentation) – even basic knowledge of these systems will be sufficient.
• Communication skills and assertiveness are important features in this position.
• Knowledge of agile validation.

Client:

Global corporation specializing in consumer products with a significant market share in its industry. The company is headquartered in a major metropolitan city and operates internationally, with products available in over 180 countries. Employing approximately 79,800 people, it is recognized as a leader in its sector.