Job Purpose:
The IT Site Lead serves as the primary on-site technology resource for MedPharm’s Stirrup Creek and Emperor Blvd facilities. This is a full-time, permanent individual contributor role responsible for the full spectrum of IT operations across both sites, including end-user support, core infrastructure management, lab informatics administration, and GxP/21 CFR Part 11 system validation. The IT Site Lead will also serve as the IT interface for a broader range of scientific and manufacturing systems — including LIMS, MES, ERP, and lab automation platforms — where the expectation is practical working knowledge and the ability to coordinate effectively with vendors and subject matter experts, rather than deep platform expertise in every system. In addition to direct technical responsibilities, the IT Site Lead will manage vendor and contractor relationships and serve as the foundational resource from which MedPharm’s Durham-area IT team will grow. The role reports directly to the Vice President of Information Technology and works in close collaboration with QA, laboratory, and operations teams to ensure a secure, compliant, and high-performing technology environment.
Summary of Key Responsibilities:
Scientific, Manufacturing & GxP Systems
- Administer Chromatography Data Systems (CDS), including Waters Empower, encompassing user account management, backup, archiving, and instrument integration
- Support and configure lab-specific systems including Empower and LAC/E; manage custom fields, system configurations, and laboratory instrument interfaces
- Serve as the IT point of contact for scientific and manufacturing systems operating within a GxP environment, including Laboratory Information Management Systems (LIMS), Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP) platforms, and lab automation or instrument control systems; deep subject matter expertise in each platform is not required, but the ability to support, troubleshoot, and coordinate with vendors and SMEs is essential
- Maintain working familiarity with GxP infrastructure considerations for Operational Technology (OT) environments, including networked laboratory instruments, SCADA systems, and PLC-connected equipment; collaborate with QA, Manufacturing, and vendor partners to ensure IT infrastructure supports validated and compliant operations
- Implement and maintain validated states for computerized systems in compliance with GxP and 21 CFR Part 11 requirements
- Develop and execute validation protocols (IQ/OQ/PQ) for IT systems and lab informatics platforms in collaboration with QA and system owners
- Collaborate with QA and laboratory teams to ensure data integrity, audit trail compliance, and adherence to change control procedures
- Support internal and external audits, addressing IT-related findings promptly and effectively
- Maintain comprehensive documentation for IT processes, validation activities, system configurations, and change control procedures in accordance with MedPharm’s quality systems
- Coordinate with vendors for system upgrades, patches, and service-level agreement compliance across both IT and lab/manufacturing systems
Infrastructure & Operations
- Provide deskside, phone, and ticket-based troubleshooting for hardware, software, and enterprise applications across the Stirrup Creek and Emperor Blvd sites
- Monitor, maintain, and repair server hardware; configure and manage virtualization platforms (e.g., Hyper-V) and backup solutions (e.g., Veeam)
- Administer Active Directory: create and disable user accounts, maintain organizational structure, and manage distribution and security groups
- Manage and configure NAS devices (Synology, QNAP) for backup and on-site data storage
- Ensure Microsoft updates are applied to all servers and endpoints in a timely and controlled manner
- Utilize remote control tools to efficiently resolve desktop and software issues
- Maintain and repair desktops, laptops, and related peripherals across both sites
- Travel between the Stirrup Creek (primary) and Emperor Blvd sites (~3 miles) as needed to deliver consistent IT support across both locations
Vendor & Contractor Management
- Serve as the primary point of contact for all IT and lab systems vendors, managing relationships, service contracts, SLAs, and escalations
- Coordinate with external vendors for system upgrades, preventive maintenance, and issue resolution
- Evaluate and onboard new vendors and contractors; ensure adherence to MedPharm security policies and compliance requirements
Collaboration & Organizational Growth
- Collaborate with the Director of IT, UK-based IT colleagues, and cross-functional teams including QA, Manufacturing, and Operations to support organizational goals
- Participate in special projects, on-call duty rotation, and strategic IT initiatives as required
- Establish operational processes, documentation, and knowledge management practices that will scale as the IT team grows
- Mentor contractors and interns as applicable; build the operational foundation for a future team of direct reports
Required Qualifications and Skills:
- Bachelor’s degree or equivalent practical experience in Information Technology, Computer Science, or a related field preferred
- 5+ years of hands-on IT support experience, ideally in a regulated pharmaceutical, biotech, or CDMO environment
- • Demonstrated experience supporting GxP-compliant systems and working within 21 CFR Part 11 regulatory frameworks
- Experience administering Chromatography Data Systems, preferably Waters Empower, including user management, backup, and instrument integration
- Proficiency with Windows Server environments, Active Directory, and Microsoft 365 administration
- Experience with virtualization platforms (Hyper-V), backup solutions (Veeam), and NAS administration (Synology, QNAP)
- Exposure to or working knowledge of scientific and manufacturing systems commonly found in regulated life sciences environments — such as LIMS, MES, ERP platforms, SCADA, or lab automation systems — is strongly preferred; intimate expertise in each system is not required, but the ability to understand their IT dependencies, support users, and coordinate with vendors is essential
- Familiarity with Operational Technology (OT) concepts and the infrastructure considerations unique to networked laboratory and manufacturing environments (e.g., instrument control networks, isolated VLANs, PLC connectivity) is a plus
- Proven ability to manage vendor relationships and hold external partners accountable to service-level agreements
- Strong documentation skills with experience developing SOPs, validation protocols, and change control records
- Self-motivated, detail-oriented, and able to operate effectively as the primary on-site IT resource with minimal supervision
- Excellent interpersonal and communication skills; able to work effectively with technical and non-technical stakeholders at all levels
- 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
Position Details:
Supervisory Responsibility: ☐ Yes ☒ No
Confidential Data: ☒ Yes ☐ No
Budgetary Responsibility: ☐ Yes ☒ No
Travel Requirements: ☒ Yes ☐ No
Travel Detail: Local travel between Stirrup Creek (primary) and Emperor Blvd (~3 miles). Personal or company vehicle required. No overnight travel anticipated.
PHYSICAL DEMAND ANALYSIS
- Work Environment: Office and laboratory environment across two sites. Includes server rooms, network closets, laboratory spaces, and general office areas. May involve occasional exposure to regulated laboratory environments
- Physical Summary: Role involves a mix of desk-based and active deskside work, including occasional lifting of IT equipment, reaching into server racks, and moving between workstations and server rooms
Occasional carrying, bending, lifting, pushing, pulling, twisting, reaching, gripping 1-33% of time. Frequent standing, walking, and hearing 34 - 66% of time. Constant sitting and seeing 67 - 100% of time.
All position requirements listed indicate the minimum level of knowledge, skills and/or experience necessary to perform the job proficiently. This position description is not to be construed as an exhaustive statement of duties, responsibilities or requirements. Employees will be required to perform any other job-related duties as requested by their supervisor, subject to reasonable accommodation.
