Application Systems Analyst
2 weeks ago
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
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