Application Systems Analyst - North Carolina, United States - Advanced Clinical

Description

Application Systems Analyst

**Must have experience within FDA / GxP / LIMS (LabWare) Pharma regulated environments. Experience with LIMS Basic and ELN are preferred.

We are currently searching for a skilled professional to join a well-known client's team as a Systems Engineer in Raleigh, North Carolina. This hybrid onsite and remote role will provide technical support for various LIMS / LabWare along with GxP and manufacturing applications such as Werum/Koerber PAS-X, Blue Mountain RAM, TraceLink, Dell Boomi, and Optel Vision Systems in a regulated, validated environment.

Responsibilities

• Participate in project initiatives for new and existing systems (enhancements or upgrades to existing systems, install new software applications, document user requirements, perform development/configuration of software, execute system and validation testing, create/revise SOP's, and conduct training)
• Collaborate with software vendors and other UT departments
• Provide break/fix and administrative maintenance support for designated systems
• Troubleshoot application errors, database errors, user login issues, and perform routine tasks
• Contribute to internal team initiatives and process improvement efforts
• Ensure the continuous, uninterrupted availability/functionality of computer systems and coordinate appropriate resources to respond to outages and emergencies

Experience

• Minimum of 3 years of experience in an FDA regulated pharmaceutical manufacturing environment, with emphasis on Quality and Manufacturing System administration, development, and support required
• Demonstrated experience with Level 1 or 2 application support
• Experience working in a computer system support environment utilizing a ticket management system to track and manage support requests
• Experience in executing projects, system life-cycle process, gathering/documenting requirements, executing protocols, and understanding of methodology for execution
• Ability to collaborate, communicate, and prioritize workload
• Manufacturing System Application support experience with Werum/Koerber PAS-X Electronic Batch Record, Blue Mountain RAM, Tracelink Serialization Management System, Optel Vision Systems, and/or ERP systems
• Demonstrated experience in full project lifecycle software application installations
• Computer hardware/software validation and change control experience
• Experience collaborating with tools such as Microsoft Teams, Sharepoint, and Smartsheets
• Knowledge of MS SQL Server and Windows Server
• System Integration experience using a Platform As A Service such as Dell Boomi preferred
• Computer system programming and software development experience preferred
• Proficient in SQL or Oracle Database Administration

EDUCATION

• Minimum of Bachelor's Degree in Information Technology, Engineering, or an applicable scientific and/or engineering discipline required