Computer System Validation Engineer

Benefits:

• Competitive salary
• Opportunity for advancement
• Training & development
  
  
  

Job Summary

We are seeking a skilled System Validation Engineer to join our team! As a System Validation Engineer, you will be responsible for

validating documentation Authoring (validation plans, user requirements specifications, risk assessment, IQ-OQ-PQ protocols, trace matrix and summary reports) and responsible for assuring a system/application meets its requirements as outlined in system specification (URS/FRS) per process defined in the Validation Plan for the project.

Responsibilities

• Validate GMP Lab systems and Equipment
• Identify and escalate, as necessary project risks and issues to the CSVC Manager
• Engage in multiple CSVC projects through the assimilation of data, establishing facts and drawing valid conclusions to deliver results in accordance with resources, constraints and business needs
• Be able to prepare reports on defects and problems that arise during system testing
• Have solid oral and written communication skills and teamwork skills
• Work with business representatives to ensure the test cases reflect business rules and processes
• Fulfills the role of a subject matter expert role for critical quality and compliance GxP end-use applications supporting Animal Health business processes
• Work with business representatives to ensure the test cases reflect business rules and processes
• Fulfills a subject matter expert role(s) for critical quality and compliance GxP end-use applications supporting Animal Health business processes.
  
  
  

Qualifications

• Be a good team player, able to meet deadlines and handle changing priorities
• Have strong judgment capabilities to clarify requirements when necessary
• Have the ability to work with cross functional teams
• Have solid experience working with validated systems
• GMP/Regulated lab, more than 5 years of CSV experience required
• Technical writing Experience
• Highly skilled in Computerized System testing and validation in the healthcare industry
• Knowledge of GxP regulations (e.g. 21 CFR Part 11, Annex 11)
• Solid project organizational skills and ability to multi-task with strong analytical problem-solving skills
• Excellent communication including written, verbal, and listening skills
• Self-motivated, detail oriented, takes initiative and ability to work independently without close supervision
• BS in Science or Technical Writing Degree