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Kyowa Kirin, Inc.- U.S. · 1 week ago

Senior IT Systems Specialist - LIMS and Lab Applications

Sanford, NC

Full-time

Onsite

Mid, Senior Level

$84K/yr - $109K/yr

5+ years exp

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines. They are seeking a Senior IT Systems Specialist - LIMS and Lab Applications to lead the ICT team in supporting the manufacturing site’s QC IT applications and ensuring compliance processes are met.

Pharmaceuticals

H1B Sponsor Likely

Responsibilities

Lead the North America & North Carolina manufacturing site ICT team in configuration, implementation, deployment and operational support of manufacturing site’s QC IT applications (i.e. LIMS, ELN & Other Lab Instrument Software and System / Instrument Integrations)

Support SDLC/ GxP validation activities related to implementation and change controls of QC IT software systems / integrations

Provide functional / technical expertise on system features, system functionality, access/security controls, master data and understanding of the business processes

Act as a System Administrator as needed (set up new users and manage security roles)

Coordinate the needs of QC functional areas and lead LIMS configurations for key business processes in LIMS system related to compliance processes, instrument calibration, quality operations, environment monitoring, CoA, stability testing, vendor compliance, manage inventory, design of queries and report, develop product sampling/test plan

Expertise in LIMS application processes, specifically LabVantage

Proficiency in LIMS interfacing, navigation, and customization to streamline workflows and enhance user experience

Experience in leading projects to conclusion, making recommendations for improved outcomes

Strong understanding and application of ITIL processes and best practices, with the ability to independently drive continuous improvement initiatives

Experience with ITSM tools and frameworks, leveraging them to optimize service delivery and align IT support with business needs

Demonstrated independence in diagnosing and resolving complex technical issues, applying sound judgment and critical thinking to identify root causes and implement effective solutions

In-depth knowledge of troubleshooting methodologies and the ability to proactively address and mitigate recurring technical challenges

Extensive experience with system administration tasks, including advanced configuration, performance tuning, and optimization to support business-critical applications

Strong understanding of security best practices, risk management, and compliance standards, ensuring robust protection of business assets and data

Excellent communication and interpersonal skills, with a focus on high-level business partnership and aligning IT support with organizational goals

Ability to manage complex customer inquiries and provide tailored, high-quality solutions that enhance employee experience and business performance

Advanced capability in creating and maintaining detailed technical documentation, ensuring knowledge sharing and alignment across teams

Experience in generating, analyzing, and presenting actionable technical reports to senior leadership, contributing to strategic decision-making

High level of customer service focus, consistently fostering positive employee and business partner relationships, and ensuring a seamless IT experience for all end users

Qualification

LIMS application processesLabVantageITIL processesSystem administrationITSM toolsGMPGDP experienceTechnical documentationMS Office SuiteCustomer service focusCommunication skillsInterpersonal skills

Required