Computer System Validation Engineer
Technoviz LLCMADISON, WI, USjob_description.job_card.30_days_ago
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job_description.job_card.job_descriptionValidate 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. 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
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
Qualifications
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Validation Engineer • MADISON, WI, US