IT / CSV Specialist

San Juan, Puerto Rico
Full Time
Experienced

PACIV, a global leader in industrial automation solutions servicing the Life Sciences sector, is seeking a IT / CSV Specialist to provide technical support for laboratory applications, systems, infrastructure, and validation activities within a pharmaceutical manufacturing environment.

Position Responsibilities / Essential Functions:
  • Provide IT support for laboratory applications such as Empower, SmartLab, and Darwin LIMS.
  • Perform user administration, troubleshooting, and support for laboratory systems.
  • Support LAC/E hardware, Citrix, Windows 10 IoT, Windows Server, and network connectivity.
  • Troubleshoot connectivity between laboratory instruments and data systems.
  • Support laboratory peripherals such as barcode scanners, printers, handheld devices, and biometric systems.
  • Author and execute IQ/OQ/PQ protocols and other CSV documentation.
  • Support change control, periodic reviews, and system retirement activities.
  • Apply knowledge of GAMP 5, 21 CFR Part 11, ALCOA+, GMP, and GLP requirements.
  • Manage GxP user accounts, roles, access reviews, and Active Directory permissions.
  • Coordinate technical support with vendors such as Waters, Agilent, and PerkinElmer.
  • Maintain accurate, audit-ready documentation and IT service records.
  • Provide technical support to laboratory users and communicate status and issues effectively.
  • Work independently and collaborate with the Local IT team as needed.
Requirements:
  • 3+ years of IT support experience in a pharmaceutical, biotechnology, or GxP environment.
  • Experience with Empower CDS administration.
  • Experience with laboratory applications such as SmartLab, LIMS, or equivalent systems.
  • Experience authoring CSV documentation, including IQ/OQ/PQ protocols.
  • Familiarity with GAMP 5 and 21 CFR Part 11.
  • Experience with Windows 10 IoT, Windows Server, Citrix, or laboratory infrastructure.
  • Experience with ServiceNow or another ITSM system.
  • Bilingual fluency in English and Spanish.
  • Ability to work independently in a regulated environment.
  • Flexible availability, including off-hours and on-call support.
Desired Skills:
  • Experience with Darwin LIMS or LabVantage.
  • Knowledge of laboratory instrument connectivity and LAC/E systems.
  • Experience with Veeva QMS, TrackWise, or other change control systems.
  • Experience supporting Raman, NIR, Nymi Band, or other specialty laboratory systems.
  • Strong troubleshooting, communication, and documentation skills.
  • Bachelor's degree in IT, Computer Science, Engineering, or a related field preferred.
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