GxP Systems Analyst, Operational Technology

Location: 100% on-site at the Durham, NC office, United States.

Company

hirify.global develops pharmaceutical therapies for rare diseases and technologies intended to expand the availability of transplantable organs.

What you will do

• Support new and existing manufacturing and laboratory systems in a regulated, validated environment.
• Configure applications, execute validation testing, create or revise SOPs, train end users, and coordinate vendors during upgrades, enhancements, installations, and other projects.
• Provide Level 1 or 2 break/fix support, including troubleshooting application and database errors, resolving login issues, managing accounts and access, and performing maintenance and testing.
• Collaborate with stakeholders to meet 21 CFR Part 11 and data integrity requirements.
• Maintain system availability and functionality, coordinate responses to outages and emergencies, and contribute to process improvement initiatives.

Requirements

• Associate degree in information technology, chemical engineering, bioengineering, or an applicable scientific or engineering discipline preferred, plus 4+ years of GxP systems support experience; or bachelor’s degree in a related discipline preferred, plus 2+ years of GxP systems support experience.
• 2+ years of experience in an FDA-regulated pharmaceutical manufacturing environment, with emphasis on manufacturing system administration, development, and support.
• Experience with Level 1 or 2 application support, ticket management systems, and manufacturing or quality system application support.
• Experience with computer hardware and software validation and change control.
• Working knowledge of MS SQL Server and Windows Server.
• Experience executing projects, following system life-cycle processes, gathering and documenting requirements, executing protocols, and applying project execution methodologies.
• Experience with Microsoft Teams, SharePoint, and Smartsheet.
• Experience supporting MasterControl, Blue Mountain RAM, TraceLink Serialization Management System, Uhlmann line management systems, and/or ERP systems.
• Ability to collaborate, communicate, prioritize workload, and work effectively on small, fast-paced project teams.

Nice to have

• PMP certification from PMI.
• System integration experience with tools such as Dell Boomi.
• Experience with standalone laboratory instruments including FTIR, endotoxin, HPLC, GC, HIAC, and plate readers.
• Experience completing full software application installation life cycles.
• Computer system programming and software development experience.
• Proficiency in SQL or Oracle database administration.

Culture & Benefits

• Full-time, 100% on-site work at the Durham, NC office.
• Benefits may include medical, dental, vision, prescription coverage, wellness resources, 401(k), ESPP, paid time off, paid parental leave, and disability benefits.
• Work supports pharmaceutical development and technologies for increasing access to transplantable organs.
• Equal opportunity employment is offered, including for veterans and individuals with disabilities.