Job Summary:
Work closely with our Service Lead to deliver the managed service, bringing together the efficient delivery of service while driving innovations and value add for our customer.
Work closely with the IT Operations, Laboratory Operations and Quality staff to support, enhance, and maintain laboratory device ecosystems and LIMS platforms. This role brings together hands‑on instrument expertise, digital lab transformation, and strong data integrity practices to ensure reliable, compliant, and future‑ready laboratory operations. You will contribute to standardization, integration, and automation initiatives across QC and R&D labs, helping the customer move toward a fully digital, connected laboratory environment
Key Responsibilities:
Responsibilities (include but are not limited to):
Laboratory Instrument Support
• Daily troubleshooting and support for analytical instruments (HPLCs, UPLCs, GC, balances, pH meters, dissolution systems, endotoxin readers, etc.)
• Investigation and resolution of device errors, communication failures, and data acquisition issues.
• Firmware upgrades, instrument health checks, and performance validation support.
LIMS / Lab System Administration
• Configure, maintain, and administer Laboratory Information Management Systems (e.g., LabWare LIMS, SampleManager, MODA, LabVantage).
• Manage LIMS master data, workflows, specifications, user roles, and integration parameters.
• Troubleshoot LIMS incidents and coordinate resolution with vendor or internal IT teams.
Integration of Laboratory Devices with LIMS / LES / CDS
• Support integration of instruments via CDS systems (Chromeleon, Empower), middleware, or direct LIMS/LES connections.
• Ensure reliable communication between lab equipment, acquisition servers, and LIMS/ELN platforms.
• Identify opportunities to automate data flows and reduce manual data entry.
Lab Digitalization & Technology Improvements
• Participate in lab digitalization initiatives (e.g., paperless lab, e‑logbooks, e‑notebooks, automated data capture).
• Perform assessments of current instrument landscape and propose modernization strategies.
• Drive continuous improvement and value‑add innovations for lab users. Participate/Contribute to systems availability solution, business continuity procedures, disaster recovery exercises and associated evidence collection
Compliance & Data Integrity
• Ensure all laboratory systems operate in compliance with GxP, ALCOA+, and 21 CFR Part 11 requirements.
• Support audits (internal/external) by providing documentation, system evidence, and validation records.
• Maintain audit‑ready configurations and support periodic reviews.
Documentation, Validation & SDLC Activities
• Create/update SDLC documentation (URS, FS, DS, HDS, SDS, IQ/OQ/PQ, validation plans, test scripts).
• Support qualification of new and existing instruments, software upgrades, and LIMS enhancements.
• Document configuration changes, risk assessments, and traceability matrices.
Change & Incident Management
• Initiate, manage, and implement approved changes following site processes.
• Support incident logging, troubleshooting, root cause identification, and preventive actions.
User Support & Training
• Provide daily user support for lab informatics platforms.
• Train laboratory staff on system functionality, best practices, and troubleshooting steps.
• Participate in the on-call rota when required.
Coordination & Reporting
• Collaborate with local and remote support teams, system vendors, and lab personnel.
• Provide weekly/monthly status reporting on supported systems, incidents, and performance metrics.
Essential Skills:
Strong experience supporting laboratory instruments in a GxP laboratory environment.
Hands‑on knowledge of analytical devices and their associated acquisition software.
Strong experience with LIMS platforms (LabWare, SampleManager, LabVantage, etc.).
Understanding of ELN, LES, CDS, and instrument‑to‑system data flows.
Knowledge of IT/OT infrastructure relevant to laboratory systems (networks, servers, Windows OS, virtual machines).
Experience with computer system validation (CSV), GAMP 5, and data integrity practices.
Ability to prioritize critical laboratory support issues and act with urgency.
Solid understanding of cybersecurity, backup/restore, and disaster recovery for lab systems.
Database creation and administration (SQL) for LIMS installation, setup, configuration and troubleshooting.
Nice to Have Skills:
Experience with laboratory automation, robotics, or integrated digital workflows.
Experience with cloud‑hosted or SaaS laboratory platforms.
Scripting or automation experience (Python, PowerShell) for data and workflow automation.
Knowledge of scientific data standards (e.g., AnIML, Allotrope).
Qualifications and Language Requirement:
Bachelor's Degree in Life Sciences, Chemistry, Engineering, IT, or related field—or equivalent professional experience.
Native - level Japanese
Business - level English
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免責事項：
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