GxP IT Operations & Lab Systems Specialist

NCBioImpact

Durham (NC)

On-site

USD 90,000 - 120,000

Full time

5 days ago

Be an early applicant

A complete application in a minute

Tailored resume and cover letter, ready to send.

Get past ATS filters

Job summary

MedPharm is seeking an IT Operations & End-User Support Specialist to join two-site teams in Durham, NC. This role combines hands-on IT support with administration of scientific systems to ensure validated, compliant operations across GxP environments.

You will manage deskside support, AD/MS 365, instrument PCs, CDS, backups, and security practices while collaborating with QA, Laboratory, and Operations to sustain reliable IT services at Stirrup Creek and Emperor Blvd.

Qualifications

Bachelor’s degree or equivalent practical experience in Information Technology, Computer Science, a scientific discipline, or a related field.
5+ years of hands-motivatd IT support or systems administration experience, including at least 3 years supporting laboratory, manufacturing, or other regulated environments; pharmaceutical, biotech, or CDMO experience strongly preferred.
Working knowledge of GxP and 21 CFR Part 11 requirements, change control, and data integrity principles.
Experience with Chromatography Data Systems, preferably Waters Empower, is strongly preferred.
Proficiency with Windows 10/11, Active Directory, and Microsoft 365 administration; familiarity with Windows Server.
Experience supporting instrument-connected PCs and scientific software in a laboratory setting.
Familiarity with PC imaging (Microsoft Intune), backup solutions (Veeam), NAS administration (Synology/QNAP), and virtualization (VMWare).
Working understanding of networking fundamentals (TCP/IP, DNS, DHCP, VLANs, Wi‑Fi).
Strong documentation skills, with experience writing or executing SOPs, test scripts, or change controls.
Customer-focused, with excellent interpersonal and communication skills; able to explain technical concepts to scientists and non‑technical staff.
Self-motivated and detail-oriented; able to manage competing priorities across two sites.
High level of professionalism and discretion when handling confidential data and sensitive systems.
Ability to travel locally between Stirrup Creek and Emperor Blvd sites as needed.
Relevant certifications (e.g., CompTIA A+/Network+/Security+, Microsoft 365, ITIL Foundation) are a plus.

Responsibilities

IT Operations & End-User Support: Provide Tier 1-2 deskside, phone, and ticket-based troubleshooting for hardware, software, and enterprise applications across the Stirrup Creek and Emperor Blvd sites, resolving issues within defined service levels.
Image, deploy, patch, maintain, and retire desktops, laptops, mobile devices, and related peripherals; maintain accurate hardware and software asset records.
Administer user accounts in Active Directory and Microsoft 365, including onboarding and offboarding, group and distribution list management, licensing, and MFA, in partnership with HR.
Ensure Microsoft updates are applied to endpoints and servers in a timely and controlled manner.
Utilize remote control tools to efficiently support desktop and software unexpected events.
Support printers, phones, conference-room and audio-visual equipment, and perform first-line troubleshooting of network connectivity (wired, Wi-Fi, VPN) while escalating as appropriate.
Assist with server, virtualization (VMWare), and backup (Veeam) operations, including job monitoring and restore requests.
Reinforce security best practices with end users, including phishing awareness, device encryption, and acceptable use.
Scientific & Laboratory Systems: Install, configure, and support PCs and software that control laboratory instruments (e.g., HPLC/UPLC, GC, dissolution and diffusion systems, FTIR, Karl-Fisher, microscopes, titrators, and spectrophotometers).
Administer Chromatography Data Systems (CDS), including Waters Empower, encompassing user and role management, system configuration, LAC/E support and instrument integration.
Own the backup, restore, and archiving process for instrument and scientific data, including NAS devices (Synology, QNAP); perform and document periodic restore tests to verify recoverability.
Maintain secure configuration of laboratory devices, including network placement, , antivirus exclusions/settings, and OS hardening of instrument workstations.
Coordinate patching and operating system upgrades on validated instrument PCs through formal change control process, working with instrument vendors, laboratory and QA personnel.
Serve as the day-to-day IT point of contact for laboratory staff and instrument service engineers during installations, upgrades, repairs, and relocations.
GxP Compliance & Documentation: Maintain validated states for computerized systems in compliance with GxP and 21 CFR Part 11 requirements and ALCOA+ data integrity principles.
Author, update and maintain SOPs, work instructions, and change control records; participate in deviations, investigations, and CAPAs related to IT systems.
Support validation activities, including drafting and executing IQ/OQ protocols and test scripts for IT systems and laboratory informatics platforms.
Perform periodic user access reviews and support audit trail reviews and periodic system reviews in collaboration with QA.
Support internal, client, and regulatory audits by providing evidence of IT controls and system documentation.
Collaboration & Vendor Coordination
Collaborate with the Manager, GxP Systems and Site Operations, Vice President of IT, UK Site Lead, IT contractors, and cross-functional teams including QA, Laboratory, Manufacturing, and Operations.
Coordinate with external IT and instrument vendors for system upgrades, preventive maintenance, and issue resolution.
Participate in special projects, on‑call duty rotation, and strategic IT initiatives as required.
Travel between the Stirrup Creek (primary) and Emperor Blvd sites (~3 miles) as needed to deliver consistent IT support across both locations.