What are the responsibilities and job description for the Computer System Validation Engineer position at Technoviz LLC?
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
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