GXP Systems Analyst, Operational Technology

Role Summary

GxP Systems Analyst, Operational Technology providing application support for manufacturing and laboratory systems in a regulated, validated environment. Responsibilities include project initiatives such as upgrades, enhancements, and new installations, as well as break/fix support, configuration, validation testing, and end-user training. Will liaise between software vendors and internal departments. On-site in Silver Spring, Maryland.

Responsibilities

• Participate in project initiatives such as system enhancements, upgrades, and new installations. Configure the software to meet user requirements, execute validation testing, create/revise SOPs, and train end users. Collaborate with software vendors and other UT departments to meet project timelines.
• Provide break/fix support for designated systems in accordance with department SLAs, including troubleshooting application and database errors, user login issues, creating user accounts, assigning access, and performing system maintenance and testing.
• Work with internal stakeholders to meet 21 CFR 11 computer regulations and data integrity requirements.
• Ensure continuous availability and functionality of computer systems and coordinate resources to respond to outages or emergencies.
• Participate in internal team initiatives and process improvement efforts.
• All other duties as required.

Qualifications

• Required: Associate degree in information technology, chemical engineering, bioengineering, or an applicable scientific/engineering discipline; or Bachelor's degree in a relevant field.
• Required: 4+ years of experience supporting GxP systems with an Associate Degree or 2+ years with a Bachelor's Degree.
• Required: 2+ years of experience in an FDA-regulated pharmaceutical manufacturing environment (manufacturing system administration, development and support).
• Required: Prior experience with Level 1 or 2 application support.
• Required: Prior experience with ticket management systems and computer system support environments.
• Required: Ability to work in a team, collaborate, communicate, and prioritize workload.
• Required: Manufacturing or Quality system application support experience; computer hardware/software validation and change control experience.
• Required: Experience with tools such as Microsoft Teams, SharePoint, and Smartsheets; working knowledge of MS SQL Server and Windows Server.
• Required: Experience in executing projects and system life-cycle processes, including requirements gathering and protocol execution.
• Required: Experience with Manufacturing or Quality System applications (MasterControl, Blue Mountain RAM, Tracelink Serialization Management System, Uhlmann line management systems, and/or ERP systems); ability to work on small, fast-paced project teams.
• Preferred: None-listed beyond the items below.

Skills

• System integration and project lifecycle experience
• SQL or Oracle database administration proficiency
• Experience with validated computer systems and change control
• Vendor liaison and cross-department collaboration

Education

• Associate or Bachelor’s degree in information technology, chemical engineering, bioengineering, or an applicable scientific/engineering discipline as specified in qualifications.