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Nitto Denko

Senior Systems Analyst, LIMS

Nitto Denko, Milford, Massachusetts, us, 01757


About this opportunity : The Senior System Analyst. LIMS is responsible for providing technology analysis, design, implementation, service, and support across the Nitto Avecia businesses. Future areas of responsibility will span applications, systems, Infrastructure, and other technologies. Key responsibilities are listed below but could include other related duties. Key Responsibilities: Acts as the primary technical lead on the LIMS project team. Responsible for system administration and support of BIOVIA LIMS / ELN systems Work closely with LIMS program manager and Lab SMEs to ensure a smooth and timely LIMS implementation. Develops and documents functional and/or technical specifications for new systems, applications, and technologies. Collaborate with Analytical Development, Process Development and Quality Control teams to ensure solutions meet team needs. Provide post-implementation support and optimization of LIMS / ELN Delivers projects and initiatives in a timely and qualitative manner. Troubleshoots technology issues across the application and infrastructure landscape (network, server, storage, system, end user devices). Assists in creating and revising documentation and qualifying systems in alignment with policies, procedures, and regulatory requirements. Follows IT Change Control policies and implements system-based policies and procedures. and confirms success of any Application, System, or Infrastructure changes (updates, repairs, upgrades, or modifications). Performs analysis, implementation and support for network, servers (physical and virtualized) storage platforms, applications, and systems. Remains current on new technologies, trends and best practices that can bring value and innovation to Nitto Avecia. Looks for opportunities to automate processes, research issues and solutions and embrace a continuous improvement philosophy. Required Skills/Abilities: BS or equivalent work experience in Information Technology related field. A minimum of 8-10 years of experience in supporting Information Technology systems, applications, and infrastructure in conjunction with lab environment systems and instruments. Proven background in large scale LIMS/ELN system project delivery, maintenance, and support. Experience with BIOVIA LIMS/ELN systems is a plus. Knowledge of process equipment, project management, and experience with working as part of a team, supporting varied and complex technologies/software required. Knowledge of validation lifecycle of lab GxP computerized systems. Strong analytical skills to identify and resolve problems and ability to effectively apply a broad range of professional concepts, practices and methods in moderately complex and diverse circumstances are required. A working knowledge of 21 CFR Part 11, 68, 210, 211, USP 1058; Computer Systems Validation and GAMP framework. Excellent communication skills with the ability to present ideas in a clear succinct manner, both verbally and in writing are required. Must be able to work independently and efficiently on several tasks at once A working knowledge in 21 CFR Part11 regulations relating to electronic data. Experience actively participating in and responding to various audits questions and findings related to IT controls.