Site IT/OT & Application Operations Lead

Kyowa Kirin•Sanford, NJ

7d•Onsite

About The Position

The Manufacturing Site IT/OT & Application Operations Lead serves as the operational owner for site IT, OT support coordination, and application services. The role runs and sustains site systems after they are built and validated so Manufacturing, QC, and Quality can rely on stable, compliant, well-supported technology. It leads incident, problem, and change coordination; service-level management; operational GMP controls; and ServiceNow-based 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 to plan and execute build-to-run transitions as systems go live, and coordinates managed service providers and vendors supporting IT and OT networks, selected IT and OT assets, and application support. It coordinates operations but does not hold System Administrator or System Owner rights for GxP applications, preserving segregation of duties. The position requires strong IT service operations experience, including support-model design and day-to-day execution in a life sciences manufacturing environment. It leads and supports site staff and works collaboratively with technical owners, project teams, system owners, vendors, and managed service providers. Leadership expectations include compassionate, people-centric leadership; team development; inclusive collaboration; stakeholder alignment; effective change management; and delivery of measurable outcomes aligned with business objectives and a patient-focused mindset. The role will initially be based at a construction site and ultimately at a biotech manufacturing site in Sanford, North Carolina. It is 100% on-site, with up to 10% domestic and limited international travel. The posting does not specify salary figures.

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.
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 managed service providers for IT networks, OT networks, infrastructure assets, or application support against contracted SLAs.
Proficiency in the Microsoft Office Suite.
Knowledge of Azure, AWS, Cisco firewalls, and switches.
Results-oriented approach, ability to navigate ambiguity, set clear outcomes, track progress, and follow through on commitments.
Strong organizational skills, attention to detail, and work ethic; ability to respond promptly and manage tasks efficiently.
Ability to adapt to change, communicate with care, listen to others’ perspectives, and manage relationships constructively.
Commitment to continuous learning, knowledge sharing, inclusive collaboration, and respectful teamwork.
Resourcefulness and proactivity in challenging the status quo, driving innovation, and developing creative solutions.
Ability to work across organizational boundaries and develop cohesive, integrated solutions.
Ability to work 100% on-site at the construction site initially and ultimately at the biotech manufacturing site in Sanford, North Carolina, and travel up to 10% domestically with limited international travel.

Nice To Haves

Bachelor’s degree in Information Technology, Computer Science, or a related field.
Experience starting up and operating a biopharmaceutical 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.
Own triage, routing, escalation, and major incident coordination for site infrastructure, OT interfaces, and site applications, ensuring 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 for infrastructure, OT support, and site applications, and prepare monthly operational dashboards for site leadership.
Define and maintain site-level managed service provider operating procedures, including ServiceNow assignment groups, escalation matrices, site access and escort requirements, and handoffs among site staff, MSPs, Application Analysts, and Engineering/Automation.
Coordinate MSP participation 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 operational service reviews, manage service credits, and escalate performance gaps to the Site ICT Director and global vendor management.
Maintain site catalog items, assignment groups, knowledge articles, and support workflows in ServiceNow 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.
Stay up to date with technology trends and advancements in the pharmaceutical and manufacturing industries.
Operate a unified IT/OT/application change process aligned to site QA change control, confirming QA approval before GxP changes are implemented, including changes performed by MSPs and vendors.
Ensure MSP and vendor activities on GxP systems and networks comply with site procedures, change control, access management, and documentation requirements; support supplier oversight and periodic supplier 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 external standards, including EHS, corporate procedures, GxP, 21 CFR Part 11, EU GMP Annex 11, and GAMP 5.
Provide operational evidence and subject-matter expertise during audits and regulatory inspections.
Lead teams by setting measurable goals, ensuring accountability, aligning resources, removing obstacles, and delivering high-quality results on time.
Communicate empathetically, listen carefully, provide helpful feedback, and handle conflicts with care.
Mentor and guide team members, support ongoing learning, and develop team members with a patient-focused mindset.
Build an inclusive and respectful environment, encourage teamwork, recognize achievements, and promote work-life balance.
Help teams navigate change and uncertainty through clear communication, flexibility, and situational leadership.
Manage stakeholders and build alignment around shared goals and patient-focused decisions.
Coordinate assigned site end-user and field-services support staff and the operations of MSPs and vendors supporting IT and OT networks, assets, and application support.

Benefits

401(k) with company matching
Annual bonus program
Generous PTO 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