IT Operations & Scientific Systems Specialist

MedPharm•Durham, NC

10d•Onsite

About The Position

The IT Operations & Scientific Systems Specialist is a hands-on, versatile, full-time individual contributor role supporting technology across MedPharm’s Stirrup Creek and Emperor Blvd facilities. The role combines day-to-day IT operations, including deskside and end-user support, with administration and support of scientific and laboratory systems such as instrument PCs, Chromatography Data Systems, and laboratory data backups. Working closely with laboratory, QA, and operations teams, the Specialist helps ensure that business and GxP-regulated systems are reliable, secure, and maintained in a validated state in accordance with 21 CFR Part 11 and MedPharm’s quality systems policies. The role reports to the Manager, GxP Systems and Site Operations. The position provides Tier 1–2 support and administration for endpoints, user accounts, Microsoft 365, servers, virtualization, backups, and related workplace technology. It also installs, configures, and supports instrument-connected PCs and scientific software, administers chromatography data systems, and manages backup, restore, and archiving processes for instrument and scientific data. The Specialist maintains regulated systems and documentation, supports validation and audit activities, and coordinates change control, patching, upgrades, and vendor work with laboratory and QA personnel. The role collaborates with IT, QA, laboratory, manufacturing, and operations teams, and requires local travel between the Stirrup Creek and Emperor Blvd sites. No overnight travel is anticipated. The work takes place in office and laboratory settings, including server rooms and network closets, and requires compliance with laboratory gowning, PPE, and safety procedures. The position has no supervisory or budgetary responsibility.

Requirements

Bachelor’s degree or equivalent practical experience in Information Technology, Computer Science, a scientific discipline, or a related field.
At least 5 years of hands-on IT support or systems administration experience, including at least 3 years supporting laboratory, manufacturing, or other regulated environments.
Working knowledge of GxP and 21 CFR Part 11 requirements, change control, and data integrity principles.
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, backup solutions, NAS administration, and virtualization.
Working understanding of networking fundamentals, including TCP/IP, DNS, DHCP, VLANs, and Wi-Fi.
Strong documentation skills, including experience writing or executing SOPs, test scripts, or change controls.
Customer-focused, with excellent interpersonal and communication skills and the ability to explain technical concepts to scientists and non-technical staff.
Self-motivated and detail-oriented, with the ability to manage competing priorities across two sites.
Professionalism and discretion when handling confidential data and sensitive systems.
Ability to travel locally between the Stirrup Creek and Emperor Blvd sites as needed.
Personal or company vehicle required for local travel.

Nice To Haves

Pharmaceutical, biotechnology, or CDMO experience is strongly preferred.
Experience with Chromatography Data Systems, preferably Waters Empower, is strongly preferred.
Relevant certifications such as CompTIA A+, Network+, or Security+, Microsoft 365, or ITIL Foundation are a plus.

Responsibilities

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 peripherals, and maintain accurate hardware and software asset records.
Administer Active Directory and Microsoft 365 user accounts, including onboarding and offboarding, groups and distribution lists, licensing, and MFA, in partnership with HR.
Ensure Microsoft updates are applied to endpoints and servers in a timely and controlled manner.
Use remote control tools to support desktop and software issues.
Support printers, phones, conference-room and audiovisual equipment, and perform first-line troubleshooting of wired, Wi-Fi, and VPN connectivity, escalating as appropriate.
Assist with server, VMware virtualization, and Veeam backup operations, including job monitoring and restore requests.
Reinforce security best practices with end users, including phishing awareness, device encryption, and acceptable use.
Install, configure, and support PCs and software controlling laboratory instruments, including HPLC/UPLC, GC, dissolution and diffusion systems, FTIR, Karl-Fisher, microscopes, titrators, and spectrophotometers.
Administer Chromatography Data Systems, including Waters Empower, covering user and role management, system configuration, LAC/E support, and instrument integration.
Own backup, restore, and archiving for instrument and scientific data, including NAS devices; perform and document periodic restore tests.
Maintain secure configurations for laboratory devices, including network placement, antivirus settings and exclusions, and instrument-workstation OS hardening.
Coordinate patching and operating-system upgrades on validated instrument PCs through formal change control, working with instrument vendors, laboratory staff, and QA.
Act as the day-to-day IT point of contact for laboratory staff and instrument service engineers during installations, upgrades, repairs, and relocations.
Maintain validated states for computerized systems in compliance with GxP, 21 CFR Part 11, 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 with QA.
Support internal, client, and regulatory audits by providing evidence of IT controls and system documentation.
Collaborate with the Manager, GxP Systems and Site Operations, Vice President of IT, UK Site Lead, IT contractors, and cross-functional QA, Laboratory, Manufacturing, and Operations teams.
Coordinate 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 locally between the Stirrup Creek and Emperor Blvd sites as needed to provide consistent IT support.