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IT / CSV Specialist

PACIV

San Juan, San Juan, Puerto RicoJobNo compensation foundTracked 1w agoSeen in employer's feed 5 days ago
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At a glance

Compensation
No compensation found
Location
San Juan, San Juan, Puerto Rico
Work Authorization
Not specified

Job overview

PACIV is hiring an IT / CSV Specialist. PACIV seeks an IT / CSV Specialist to deliver technical support for laboratory applications, systems, and infrastructure within a regulated pharmaceutical manufacturing setting, handling user administration, troubleshooting, validation protocols, and audit‑ready documentation while collaborating with vendors and the local IT team.

Key focus areas include Provide IT support for laboratory applications such as Empower, SmartLab, and Darwin LIMS., Perform user administration, troubleshooting, and support for laboratory systems., and Support LAC/E hardware, Citrix, Windows 10 IoT, Windows Server, and network connectivity..

Important skills include Empower, SmartLab, Citrix, Windows 10 IoT, Windows, and IQ/OQ/PQ Protocol Authoring. Preferred (not required): Darwin Lims, Troubleshooting, Communication, and Documentation.

Skills & qualifications

RequiredNice to have

Skills

EmpowerSmartLabDarwin LimsCitrixWindows 10 IoTWindowsIQ/OQ/PQ Protocol AuthoringGAMP 521 CFR Part 11ServiceNowITSM SystemEnglish Spanish Bilingual FluencyTroubleshootingCommunicationDocumentation

Qualifications

3+ Years IT Support Experience in Pharmaceutical or Biotech GxP EnvironmentExperience With Empower CDS AdministrationExperience With Laboratory Applications Such as SmartLab or LIMSExperience Authoring CSV Documentation Including IQ/OQ/PQ ProtocolsFamiliarity With GAMP 5 and 21 CFR Part 11Experience With Windows 10 IoT Windows Server and CitrixExperience With ServiceNow or Another ITSM SystemBilingual Fluency in English and SpanishAbility to Work Independently in Regulated EnvironmentFlexible Availability Including Off‑Hours and on‑Call SupportExperience With Darwin LIMS or LabVantageKnowledge of Laboratory Instrument Connectivity and LAC/E Systems

Full 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.

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