The individual in this position implements policies and procedures to qualify IT infrastructure platforms and validate computer systems.
Plans, coordinates, and participates in a compliant qualification process for qualifying information technology infrastructure platforms which requires formal qualification documentation under appropriate regulatory requirements and company standards.
As a Sr QA Validation Specialist (IT Infrastructure) typical day might include, but is not limited to, the following: Analysing the results of testing and determines the acceptability of results against predetermined criteria Investigating and troubleshooting problems which occur and determines solutions or recommendations for changes and/or improvements Identifying current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation vital to ensure compliance within the operation Leading process improvement projects to improve the qualification of infrastructure platforms Coordinating with other departments or outside contractors/vendors to complete validation tasks Participating in regulatory audits and communicates company's computer validation policies Assessing company's infrastructure platforms and identifies any potential security gaps and ensure the best data integrity practices are implemented Training Specialists and Technicians Technical writing experience Generating, reviewing, and approving of qualification/validation documents Completing risk assessments in relation to IT infrastructure activities Advising and supporting all teams on IT infrastructure and computer systems qualification activities This position might for you if: You have experience with principles of infrastructure and VMware in the Private & Hybrid Cloud domain, as well as an understanding of network infrastructure devices, firewalls and active directory administration You have solid understanding and experience with Computer Systems Validation and/or IT Auditing You have an understanding of the interdependencies of change management, deviation and continuous improvement You have the ability to work in a dynamic organization where innovative solutions are required to ensure a high-level of quality is achieved within required timelines You possess a thorough understanding and experience of Validation Principles with good knowledge of GAMP 5, ICH Q7A, FDA parts 210 and 211 To be considered for this position you must hold a Bachelor's degree in Computer Science, Information Systems, or a related field with at least 5+ years of experience in IT CSV engineering or a related field.
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We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
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The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
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For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency.
If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
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Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted.
The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.