IT CSV Engineer

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Overview and responsibilities and requirements are listed below.

• Works with the project team to author qualification deliverables such as Infrastructure/Network specifications, Qualification Protocols, Test Cases, Risk Assessments, and Summary Reports.
• Develop system development life cycle documents related to site infrastructure. This includes system specification documents, qualification plans and test protocols, and procedures.
• Coordinate qualification activities, propose and implement qualification strategies.
• Support the operational team to plan and execute the qualification of IT infrastructure components and the necessary infrastructure qualification activities for changes.
• Review qualification of infrastructure related to computerized systems and cloud-based services.
• Provide guidance on qualification of systems, migrations, and updates to ensure quality processes are executed as defined by procedures.
• Work with regional project teams to ensure global ITQA qualification strategy is understood and followed.
• Support infrastructure qualification and change control processes.
• Support IT in establishing and maintaining an IT infrastructure qualified for intended use.
• Work closely and collaboratively with System Owners to implement new computerized systems effectively and efficiently, system upgrades or system modifications.
• Collaborates with peers in the technical IT groups and provide input into technical architectural design, development, and implementation of network infrastructure.
• Review and update infrastructure qualification related procedures, templates, protocols, work instructions, and forms as needed to improve the qualification program.
• Take ownership of related tasks, work under minimal supervision, utilize the industry experience and best judgment to make decisions.
• Maintain up-to-date knowledge and understanding of quality system requirements as they apply to infrastructure in accordance with GxP regulations, GAMP, industry standards, policies, and procedures.

• Minimum of 4+ years of experience with infrastructure qualification in the pharmaceutical or similar regulated industry.
• Experience in providing oversight in implementing and maintaining GxP computer systems, cloud-based platforms, internal hosted systems in a qualified state.
• Experience in the creation and execution of infrastructure qualification strategies.
• Hands on experience with servers, storage, networking, and large-scale distributed systems.
• Proficiency with regulations related to GxP, knowledge of GAMP 5, and use of computerized quality management systems.

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