LIMS Master Data Specialist III

Hartmann Young; New York (NY); On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Hartmann Young is partnering with a global contract development organisation in New York, seeking a LIMS Data Specialist to create and revise master data elements, enforce data integrity, and map workflows to system capabilities.

You will collaborate with QC SMEs, IT, QA, and System Admin to develop, test, and implement new functionality; support audits; and own SOPs, data maps, and validation documentation for LIMS. Relocation support is available for this onsite role.

Qualifications

• Associate’s or Bachelor’s degree in Life Sciences, Engineering, or a related STEM field.
• Minimum 2–5 years of experience in a GMP-regulated pharmaceutical or life sciences laboratory environment.
• Experience with LIMS platforms as an end user and/or participation in an LIMS implementation.
• Understanding of analytical testing and techniques.

Responsibilities

• Create and revise master data elements in the LIMS platform, including test methods, specifications, analytical procedures, sampling plans, product parameters, and instrument mapping.
• Enforce data integrity standards, version control, and data accuracy across laboratory processes; ensure compliance with FDA 21 CFR Part 11, cGMP, ISO 17025.
• Partner with SMEs and IT to gather requirements and map workflows to system capabilities; develop and test new functionality.
• Serve as first line of support for end-user issues; troubleshoot data anomalies and assist with data migration during upgrades.
• Own and update Master Data SOPs, data maps, and validation documentation for LIMS.
• Build and maintain test definitions, sampling plans, specifications, and stability protocols in LIMS with QC involvement.
• Collaborate with IT, QA, and QC leadership to test system settings, roles, and permissions.
• Support regulatory audits by providing LIMS documentation and system access.

Skills

LIMS data management

GMP knowledge

Data integrity

Documentation

Education

Associate’s degree in Life Sciences or related field

Bachelor’s degree in Life Sciences or related field

Tools

LIMS software

Job description

Please note, this is a full-time onsite position - relocation support is available for this opportunity.

Hartmann Young are currently partnered with a well known, global contract development manufacturing organisation (CDMO), who are looking to expand their team in New York.

Role overview:

• Create and revise master data elements in the LIMS platform, including test methods, specifications, analytical procedures, sampling plans, product parameters, and instrument mapping.
• Enforce data integrity standards, version control, and data accuracy across all laboratory processes. Ensure compliance with global corporate policies and regulatory standards (e.g., FDA 21 CFR Part 11, cGMP, ISO 17025.)
• Partner with lab subject matter experts (SMEs) to gather business requirements and map existing workflows to system capabilities. Partner with IT System Admin to develop, test and implement new functionality.
• Serve as the first line of support for end-user issues, troubleshoot master data anomalies, and assist with data migration during system upgrades. Support routine troubleshooting of data-related issues and elevate technical problems to System Admin or vendor as needed.
• Own and update Master Data Standard Operating Procedures (SOPs), data maps, and validation documentation associated with LIMS.
• Build and maintain test definitions, sampling plans, specifications, and stability protocols in LIMS, in collaboration with QC SMEs.
• Work closely with IT, QA, and QC leadership to test system settings, user roles, and permissions.
• Support internal and external regulatory audits and inspections by providing LIMS documentation and system access as required.
• Execute validation test scripts associated with LIMS.
• Work with QC leadership to support ongoing LIMS improvements and upgrades.

Requirements:

• Associate’s or Bachelor’s degree in in Life Sciences, Engineering, or a related STEM field.
• Minimum of 2-5 years of experience in a GMP-regulated pharmaceutical or life sciences laboratory environment.
• Experience with LIMS platforms as an end user and/or participation in an LIMS implementation.
• Understanding of analytical testing and techniques

Due to the high volume of applications, we cannot guarantee a response with detailed feedback.