Computer System Validation Engineer

Benefits:

n

Competitive salary

n

Opportunity for advancement

n

Training & development

n

Job Summary

n

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.

n

Responsibilities

n

Validate GMP Lab systems and Equipment

n

Identify and escalate, as necessary project risks and issues to the CSVC Manager

n

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

n

Be able to prepare reports on defects and problems that arise during system testing

n

Have solid oral and written communication skills and teamwork skills

n

Work with business representatives to ensure the test cases reflect business rules and processes

n

Fulfills the role of a subject matter expert role for critical quality and compliance GxP end-use applications supporting Animal Health business processes

n

Work with business representatives to ensure the test cases reflect business rules and processes

n

Fulfills a subject matter expert role(s) for critical quality and compliance GxP end-use applications supporting Animal Health business processes.

n

Qualifications

n

Be a good team player, able to meet deadlines and handle changing priorities

n

Have strong judgment capabilities to clarify requirements when necessary

n

Have the ability to work with cross functional teams

n

Have solid experience working with validated systems

n

GMP/Regulated lab, more than 5 years of CSV experience required

n

Technical writing Experience

n

Highly skilled in Computerized System testing and validation in the healthcare industry

n

Knowledge of GxP regulations (e.g. 21 CFR Part 11, Annex 11)

n

Solid project organizational skills and ability to multi-task with strong analytical problem-solving skills

n

Excellent communication including written, verbal, and listening skills

n

Self-motivated, detail oriented, takes initiative and ability to work independently without close supervision

n

BS in Science or Technical Writing Degree