Summary of Job Description
This position is responsible for implementing policies and procedures to qualify IT infrastructure platforms and validate computer systems.
* Analyzing test results and determining their acceptability against predetermined criteria
* Investigating and troubleshooting problems that occur, and identifying solutions or recommendations for changes and improvements
* Identifying current and anticipated requirements for compliant computerized operations, and suggesting methods for the identification, implementation, and maintenance of vital procedures, actions, and documentation
* 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 communicating company computer validation policies
* Assessing company infrastructure platforms and identifying potential security gaps, ensuring best data integrity practices are implemented
* Training specialists and technicians
* Generating, reviewing, and approving qualification/validation documents
* Completing risk assessments related to IT infrastructure activities
* Advising and supporting all teams on IT infrastructure and computer systems qualification activities
Requirements and Qualifications
* 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
* Solid understanding and experience with Computer Systems Validation and/or IT Auditing
* Understanding of interdependencies of change management, deviation, and continuous improvement
* Ability to work in a dynamic organization where innovative solutions are required to ensure high-quality results within required timelines
* Thorough understanding and experience of Validation Principles with good knowledge of GAMP 5, ICH Q7 A, FDA parts 210 and 211
Education and Experience
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.