Computer System Validation Engineer

Job Description

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

Full-time