Site IT/OT & Application Operations Lead

Kyowa Kirin North America • Sanford, NC

8d • Onsite

About The Position

The Site IT/OT & Application Operations Lead is the operational owner for site IT, OT support coordination, and application services. The role sustains site systems after they are built and validated so Manufacturing, QC, Quality, laboratory, and office users have stable, compliant, well-supported technology. It leads incident, problem, and change coordination, service level management, operational GMP controls, and ServiceNow support processes across site infrastructure, OT interfaces, and GxP applications such as MES, LIMS, and site ERP functions. The role partners with the Plant IT Infrastructure Lead and project teams to plan build-to-run transitions as systems go live, and coordinates managed service providers (MSPs) and vendors supporting networks, selected IT and OT assets, and applications. It coordinates operations but does not hold System Administrator or System Owner rights for GxP applications, preserving segregation of duties.

The position provides people-centric leadership, supporting team development and fostering a collaborative, inclusive, and supportive environment. It aligns stakeholders, manages change and uncertainty, and focuses on measurable outcomes consistent with the organization’s values and patient-focused mission.

The role is initially based at a construction site and ultimately at a biotech manufacturing site in Sanford, North Carolina. It is 100% on-site and requires up to 10% domestic and limited international travel.

Requirements

• At least 5 years of overall IT experience, including a minimum of 3 years working in Manufacturing.
• Strong knowledge across several IT disciplines, including networking, security, infrastructure, and manufacturing systems.
• Good working knowledge of virtual server environments and experience with cloud server infrastructure.
• Experience with network monitoring and troubleshooting tools.
• Hands-on experience with data backup and restore, data archiving and retrieval, and server image backup and restore methodologies.
• Hands-on experience running incident, problem, and change processes in ServiceNow or a similar ITSM platform using ITIL service management practices.
• Experience supporting manufacturing and laboratory systems such as MES, LIMS, ERP, EAMS/CMMS, or BMS/EMS in a GMP environment.
• Experience coordinating MSPs for IT networks, OT networks, infrastructure assets, or application support against contracted SLAs.
• Proficiency in Microsoft Office Suite.
• Knowledge of Azure, AWS, Cisco firewalls, and switches.
• Strong organizational skills, attention to detail, communication, collaboration, adaptability, accountability, and ability to navigate ambiguity and foster alignment in a global environment.

Nice To Haves

• A bachelor’s degree in Information Technology, Computer Science, or a related field is a plus.
• Experience starting up and operating a biopharma manufacturing facility.

Responsibilities

• Serve as the accountable operations leader and single point of contact for site IT, OT support coordination, and application services for manufacturing, laboratory, and office users.
• Define and operate the site support model, including runbooks, support hours, on-call rotations, and escalation paths.
• Partner with the Plant IT Infrastructure Lead and project teams to plan and execute build-to-run handovers as systems reach validated state.
• Lead triage, routing, escalation, and major incident coordination for site infrastructure, OT interfaces, and applications, including consistent GxP incident flagging.
• Lead problem management and root-cause analysis for recurring issues and drive permanent fixes with technical owners.
• Track and report service levels and produce monthly operational dashboards for site leadership.
• Define and maintain site-level MSP procedures, including ServiceNow assignment groups, escalation matrices, site access and escort requirements, and operational handoffs.
• Coordinate MSP involvement in major incidents, root-cause analysis, and problem resolution, and track corrective actions through closure.
• Monitor and report MSP and vendor SLA performance, conduct monthly service reviews, manage service credits, and escalate performance gaps.
• Maintain ServiceNow catalog items, assignment groups, knowledge articles, and support workflows in alignment with global ITSM standards; use ServiceNow data to reduce repeat incidents and improve first-time resolution.
• Provide and coordinate technical support and troubleshooting for end users, including shop-floor and laboratory users.
• Work with system owners to maintain the computer systems inventory and support assignments for each system.
• Keep up to date with technology trends and advancements in the pharmaceutical and manufacturing industries.
• Operate a unified IT/OT/application change process aligned with site QA change control and confirm QA approval before GxP changes are implemented, including changes by MSPs and vendors.
• Ensure MSP and vendor activities on GxP systems and networks follow site procedures for change control, access management, and documentation; support supplier oversight and periodic assessments with IT Quality.
• Coordinate application downtime procedures, business continuity, and recovery exercises with system users and technical owners.
• Ensure compliance with regulatory requirements and applicable EHS, corporate, and GxP standards, including 21 CFR Part 11, EU GMP Annex 11, and GAMP 5.
• Provide operational evidence and subject-matter expertise during audits and regulatory inspections.
• Lead and develop team members through clear goals, accountability, feedback, mentoring, learning support, inclusive collaboration, and change management.
• Coordinate operational work of assigned site end-user and field services support staff and MSPs/vendors supporting IT and OT networks, assets, and applications.

Benefits

• 401(k) with company matching
• Annual bonus program (sales bonus for sales jobs)
• Generous paid time off and holiday schedule, including summer and winter shutdowns, sick days, and volunteer days
• Medical, dental, prescription drug, and vision healthcare benefits
• HSA and FSA programs
• Well-being and work/life programs
• Long-term incentive program, subject to job level and performance
• Life and disability insurance
• Concierge service
• Pet insurance
• Tuition assistance
• Employee referral awards

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed