Lab IT & Equipment Support Specialist

Nsc Global; Penzberg; On-site; EUR 52,000 - 70,000; Full time

Job summary

NSC Global is seeking a Lab IT & Equipment Support Specialist to manage laboratory IT infrastructure and analytical instruments. This on-site role operates in clean-room environments and requires strict adherence to GxP and 21 CFR Part 11 data integrity standards.

You will bridge laboratory operations and IT, ensuring HPLC, CDS, LIMS, and ELN platforms function seamlessly, with hands-on hardware troubleshooting and qualification testing.

Qualifications

• CDS platforms: Empower, Chromeleon, OpenLAB experience.
• LIMS/LES/ELN administration and hardware integration.
• IQ/OQ/PQ protocols and validation lifecycle support.

Responsibilities

• Interface and maintain instrument connectivity (HPLC, pH meters, balances, etc.).
• Support CDS/LIMS hardware integration and lab network management.
• Assist in hardware qualifications and IQ/OQ/PQ testing.
• Adhere to GMP clean-room protocols and data integrity standards (21 CFR Part 11, EU Annex 11).
• Provide ELN user administration and end-user support.

Skills

CDS support

LIMS/ELN administration

IQ/OQ/PQ testing

GxP/data integrity

Lab network troubleshooting

Clean-room procedures

Tools

Empower

Chromeleon

OpenLAB

LIMS/LES

ELN

Job description

Overview

NSC Global is seeking a Lab IT & Equipment Support Specialist to manage, maintain, and support laboratory IT infrastructure and analytical instruments. This role requires 100% on-site presence within clean-room and controlled laboratory environments to perform instrument connectivity setups, hardware-level troubleshooting, and IQ/OQ/PQ qualification testing.

You will play a critical role in bridging laboratory operations and IT, ensuring that analytical systems (such as HPLC, CDS, LIMS, and ELN platforms) function seamlessly while strictly adhering to GxP and 21 CFR Part 11 data integrity standards.

Responsibilities

• Instrument IT Connectivity & Integration: Interface and maintain connectivity for laboratory instruments, including HPLC systems, dissolution apparatus, analytical balances, pH meters, and spectroscopy equipment.

• LIMS & CDS Support: Support LIMS/LES hardware integration, lab network management, and Chromatography Data Systems (CDS) such as Waters Empower, Thermo Scientific Chromeleon, and Agilent OpenLAB.

• Equipment Qualification (IQ/OQ/PQ): Assist in hardware-level testing, installation, operational, and performance qualifications (IQ/OQ/PQ) for analytical laboratory systems.

• Clean-Room & Lab IT Operations: Follow GMP laboratory access protocols and clean-room procedures to deliver hands-on technical and network support.

• ELN & Software Administration: Provide user administration, system setup, and end-user support for Electronic Lab Notebook (ELN) applications.

• Data Integrity & Compliance: Enforce GxP compliance and electronic record/signature regulations (21 CFR Part 11, EU Annex 11) across all laboratory instruments and data repositories.

Qualifications

Technical Qualifications & Skills

• Chromatography Data Systems (CDS): Hands-on experience supporting platforms like Empower, Chromeleon, or OpenLAB.
• Lab Informatics & Systems: Working knowledge of LIMS, LES, and ELN administration and hardware integration.
• Lab Equipment Qualification: Familiarity with IQ/OQ/PQ protocols and validation lifecycle support for analytical instrumentation.
• Data Integrity Standards: In-depth understanding of GxP data integrity regulations, specifically FDA 21 CFR Part 11 and EU Annex 11.
• Network & Hardware Troubleshooting: Skill in setting up and troubleshooting laboratory network infrastructure, serial/Ethernet instrument interfaces, and peripherals.
• Regulatory Compliance: Knowledge of GMP laboratory access rules and clean-room operational standards.

Site & Work Requirements

• On-Site Physical Access: Must be physically present on-site to interact directly with benchtop instruments, analytical systems, and lab network hardware. Remote work is not applicable for this position.
• Clean-Room & GxP Compliance: Ability to strictly follow gowning protocols, clean-room safety standards, and site security clearances.