GxP IT/CSV Specialist: Empower, LIMS & Validation

PACIV; San Juan (PR); On-site; USD 70,000 - 95,000; Full time

Job summary

PACIV in Puerto Rico is seeking an IT / CSV Specialist to provide technical support for laboratory applications, systems, infrastructure, and validation activities within a pharmaceutical manufacturing environment.

You will support Empower CDS, SmartLab, LIMS, and related infrastructure, author IQ/OQ/PQ CSV documentation, and ensure GxP compliance. The role requires bilingual English/Spanish and the ability to work independently in a regulated setting, with off-hours support as needed.

Qualifications

• 3+ years of IT support in pharma, biotech, or GxP environment.
• Experience with Empower CDS administration.
• Experience with lab applications such as SmartLab, LIMS, or equivalent.
• 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 related infra.
• Experience with ITSM systems like ServiceNow.
• Bilingual fluency in English and Spanish.
• Ability to work independently in a regulated environment.
• Flexible availability, including off-hours/on-call.

Responsibilities

• 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.

Skills

IT support

Empower CDS administration

GxP environment knowledge

Bilingual English/Spanish

Documentation & communication

Education

Bachelor's degree in IT or related field

Tools

Empower CDS

SmartLab

LIMS

Citrix

Windows Server

ServiceNow

Job description

PACIV in Puerto Rico is seeking an IT / CSV Specialist to provide technical support for laboratory applications, systems, infrastructure, and validation activities within a pharmaceutical manufacturing environment.

You will support Empower CDS, SmartLab, LIMS, and related infrastructure, author IQ/OQ/PQ CSV documentation, and ensure GxP compliance. The role requires bilingual English/Spanish and the ability to work independently in a regulated setting, with off-hours support as needed.