5+ years in IT/Business Analysis within GxP/Pharmaceutical settings
Proficient with ServiceNow, TrackWise, Veeva, and AD systems
Familiar with lab software like Empower, Chromeleon, and LabX
Bachelor's degree in IT, Computer Science, Engineering, or Business Administration
Experience with computer system validation and GxP compliance
Responsibilities
Support Quality Control IT operations and computer system validation processes
Provide triage for system downtime and coordinate vendor repairs
Handle upgrades from Windows 7 to 10 and perform system decommissioning
Author and execute SDLC validation artifacts ensuring compliance with 21 CFR Part 11
Provide technical oversight and application support for various laboratory instruments
Full Job Description
Key Responsibilities:
GMP / GxP Operations: Support Quality Control IT operations, computer system validation (CSV) periodic reviews (backup/restore testing, user access, audit trails), and GxP workstation patching.
Front-Line Support & Decommissioning: Provide triage for system downtime, coordinate vendor repairs, handle Windows 7 to 10 upgrades, and perform system decommissioning (account deactivations, final backups).
Documentation & Testing: Author and execute SDLC validation artifacts (URS, FRA, IQ, IOQ, ATR, Admin SOPs, Data Flow diagrams) adhering to 21 CFR Part 11 and Data Integrity compliance.
Lab Instrument Support: Provide technical oversight and application support for lab equipment (e.g., Vaya Raman, 7500 Fast PCR, Hiac Particle Counters, Maldi-TOF, Vi-Cell, Antaris II, Waters Alliance).
Education and Experience:
Experience: 5+ years of IT/Business Analysis experience supporting software implementations in GxP/Pharmaceutical environments.
Key Tools & Systems: ServiceNow (Incident/Change/Problem), TrackWise (CAPA, Deviations), Veeva, Active Directory, MyAccess, and NTFS permissions.
Lab Software Knowledge: Empower, Chromeleon, LabX, WinKQCL, or related GxP laboratory desktop software.
Education: Bachelor's degree in IT, CS, Engineering, or Business Administration (or equivalent).
