What are the responsibilities and job description for the IT / CSV Specialist position at PACIV?
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.
- 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.
- 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.