Senior Specialist LIMS

Hartmann Young; New York (NY); On-site; USD 120,000 - 160,000; Full time

Job summary

Hartmann Young, partnered with a global CDMO, seeks a senior LIMS Lead for its New York quality control laboratory. You will oversee LIMS operations, support enhancements and integrations, and ensure data integrity and FDA 21 CFR Part 11 compliance.

You will develop SOPs, train staff, map workflows, write test definitions, and collaborate with IT to validate and automate connections to analytical instruments.

Qualifications

• Minimum of 8 years of experience with pharma laboratory applications (LIMS, LES, ELN).
• Experience with LabVantage LIMS master data building.
• Understanding of GxP, data integrity, and computer system validation requirements.
• Experience writing and updating technical documentation, SOPs, and training materials.

Responsibilities

• Lead and oversee LIMS within the QC laboratory; support enhancements and integrations.
• Execute validation activities, ensuring compliance with GxP, data integrity, and CSV requirements.
• Maintain and update technical documentation, SOPs, and training materials.
• Provide support and training on LIMS including new system functionalities.
• Enforce data integrity standards, version control, and data accuracy across all laboratory processes.
• Partner with lab SMEs to gather business requirements and map workflows to system capabilities.
• Own and update LIMS SOPs and build test definitions, sampling plans, specifications, and stability protocols.
• Support troubleshooting of data-related issues and collaborate with IT on test scripts for integrations.
• Lead QA and QC to test system settings, user roles, and permissions.
• Support internal and external regulatory audits and inspections.
• Lead QC ongoing LIMS improvements and upgrades.

Skills

LIMS

GxP understanding

Data integrity

Validation

SOP documentation

Education

Bachelor’s degree in Chemistry, Biology, Life Sciences or related field

Tools

LabVantage LIMS

Job description

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.

The role:

• Lead and oversee LIMS within the quality control laboratory; support enhancements and integrations.
• Execute validation activities, ensuring compliance with GxP, data integrity, and CSV requirements.
• Maintain and update technical documentation, SOPs, and training materials.
• Provide support and training on LIMS including new system functionalities.
• 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.
• Own and update LIMS Standard Operating Procedures (SOPs)
• Build and maintain test definitions, sampling plans, specifications, and stability protocols in LIMS, in collaboration with QC SMEs.
• Support troubleshooting of data-related issues.
• Work with IT System Administrator to develop user requirements and test scripts for custom scripts, code, or automation tools to support LIMS integration with analytical instruments and other enterprise systems.
• Lead QA and QC to test system settings, user roles, and permissions.
• Support internal and external regulatory audits and inspections.
• Lead QC ongoing LIMS improvements and upgrades.

Requirements:

• Bachelor’s degree in Chemistry, Biology, Life Sciences or related field.
• Minimum of 8 years of experience with pharma laboratory applications (LIMS, LES, ELN).
• Experience with LabVantage LIMS master data building.
• Understanding of GxP, data integrity, and computer system validation requirements.
• Understanding of analytical testing and techniques.
• Experience writing and updating technical documentation, SOPs, and training materials.

If this is an opportunity of interest, please reach out or apply. We'd love to hear from you!