IT / CSV Specialist

San Juan

Full-time

30+ days ago

Job Description

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.

Numbers & Facts

Location	San Juan
Job Type	Full-time
Website	http://www.paciv.com

Skills

Automationunmatched
Bar Code Printersunmatched
Bar Code Scannersunmatched
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Change Controlunmatched
Citrix Product Familyunmatched
Code of Federal Regulationsunmatched
Communication Skillsunmatched
Computer Scienceunmatched
Control Systemsunmatched
Document Scannersunmatched
Documentationunmatched
Drug Manufacturingunmatched
English Languageunmatched
GLP (Good Laboratory Practices)unmatched
GMP (Good Manufacturing Practices)unmatched
GxPunmatched
IT Service Management (ITSM)unmatched
Identify Issuesunmatched
Information Technology & Information Systemsunmatched
Internet of Thingsunmatched
Laboratory Information Management System (LIMS)unmatched
Laboratory Systemsunmatched
Microsoft Active Directoryunmatched
Microsoft Windows Operating Systemunmatched
Microsoft Windows Serverunmatched
Mobile Devicesunmatched
Multilingualunmatched
Network Connectivityunmatched
On Callunmatched
Peripheral Hardwareunmatched
Printersunmatched
Process Validationunmatched
ServiceNowunmatched
Software Administrationunmatched
Spanish Languageunmatched
Technical Leadershipunmatched
Technical Supportunmatched
User Account Administrationunmatched
Writing Skillsunmatched

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