Lab Informatics Specialist

VMC Soft Technologies, Inc; Hyderabad; On-site; INR 900,000 - 1,500,000; Full time

Job summary

VMC Soft Technologies, Inc is seeking a Lab Informatics Specialist with deep Chromeleon CDS (Thermo Fisher) and ELN expertise to support regulated labs. The role covers configuration, validation, data integrity, and cross‑functional collaboration.

Responsibilities include administering Chromeleon CDS, ELN platforms, IQ/OQ/PQ validation, and GMP/GLP/21 CFR Part 11 compliance. Collaboration with QA/QC, IT, and Lab teams is essential, along with training and SOP maintenance.

Qualifications

• 8–10 years of experience in Lab Informatics, Laboratory Systems, or Life Sciences IT.
• Experience in regulated environments (pharmaceutical/biotech/CRO).
• Exposure to CSV and computer system validation practices.

Responsibilities

• Manage and support Chromeleon CDS across lab environments.
• Administer and maintain ELN platforms ensuring data integrity.
• Perform IQ/OQ/PQ validation, document outcomes and compliance reviews.
• Collaborate with Lab, QA/QC, and IT teams to gather requirements and implement solutions.
• Ensure GMP, GLP, and 21 CFR Part 11 compliance for systems.
• Troubleshoot issues, perform root cause analysis, and implement fixes.
• Support data migration, system upgrades, and integrations with LIMS/ERP.
• Develop and maintain SOPs, validation docs, and training materials.
• Deliver end-user training and ongoing application support.
• Identify continuous improvements for informatics workflows.

Skills

Chromeleon CDS

ELN platforms

IQ/OQ/PQ validation

GMP/GLP/21 CFR Part 11

LIMS/ERP integration

Data migration

Troubleshooting

Documentation

Stakeholder management

Job description

Hiring: Lab Informatics Specialist (Chromeleon CDS & ELN)

Experience: 8 10 Years

Location: [Add Location]

Employment Type: [Full-Time / C2H]

We are looking for an experienced Lab Informatics Specialist with strong expertise in Chromeleon CDS (Thermo Fisher), Electronic Lab Notebook (ELN) platforms, and laboratory system validation. The ideal candidate will have experience supporting regulated laboratory environments and ensuring compliance with industry standards.

Key Responsibilities

• Manage, configure, and support Chromeleon CDS (Thermo Fisher) across laboratory environments.
• Administer and maintain Electronic Lab Notebook (ELN) platforms, ensuring data integrity and system reliability.
• Perform system validation activities, including IQ/OQ/PQ, documentation, and compliance reviews.
• Collaborate with Laboratory, QA/QC, and IT teams to gather business requirements and implement effective solutions.
• Ensure compliance with GMP, GLP, and 21 CFR Part 11 regulatory requirements.
• Troubleshoot system issues, perform root cause analysis, and implement timely resolutions.
• Support data migration, system upgrades, and integrations with enterprise applications such as LIMS and ERP.
• Develop and maintain SOPs, user guides, validation documentation, and training materials.
• Deliver end-user training and provide ongoing application support.
• Identify and implement continuous improvements for laboratory informatics systems and workflows.

Required Skills

• Hands-on experience with Chromeleon CDS (Thermo Fisher) administration and support.
• Strong knowledge of Electronic Lab Notebook (ELN) platforms.
• Experience with laboratory system validation (IQ/OQ/PQ).
• Understanding of GMP, GLP, and 21 CFR Part 11 compliance.
• Experience with LIMS, ERP integration, and data migration.
• Excellent troubleshooting, analytical, and documentation skills.
• Strong communication and stakeholder management abilities.

Preferred Qualifications

• 8 10 years of experience in Lab Informatics, Laboratory Systems, or Life Sciences IT.
• Experience working in Pharmaceutical, Biotechnology, CRO, or Life Sciences organizations.
• Exposure to regulated laboratory environments and computer system validation (CSV).