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.
Skills Required
- 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 or LIMS
- Experience authoring CSV documentation including IQ/OQ/PQ protocols
- Familiarity with GAMP 5 and 21 CFR Part 11 (ALCOA+, GMP, GLP)
- Experience with Windows 10 IoT, Windows Server, Citrix, and 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
- 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 related field
What We Do
PACIV, Inc. (Process Automation – Controls.Instruments.Validations) was founded and registered as a corporation in the Commonwealth of Puerto Rico in 1997. Listening to our clients' desire for local support and standardization among their facilities, we opened our Indiana office (PACIV-USA, LLC) in 2003. Moreover, in 2011 we opened PACIV-Ireland in Cork, Ireland. Our expansion, including international presence with local resources, responds to the needs of our Life Sciences multinational clients regarding replication and consistency of implementation, who demand our life sciences automation and regulatory compliance solutions in a localized market format. Our thorough understanding of the challenges faced by the Life Science sector and our collaborative approach with our clients has enabled us to become a leading Life Sciences automation and regulatory compliance service company. Since our inception, we provide our Life Sciences clients with our services in their multiple manufacturing sites worldwide. The fact that we hold Master Service Agreements (MSA’s) and Preferred Vendor status with the world’s leading Life Science Companies serves a testimony of our quality of service and leadership standing within the Life Science industry. We attract and develop the best talent which allows us to provide our demanding clients with the right knowledge and expertise ensuring we provide significant value within our automation solutions and services.
