Senior LIMS Lead – Pharma QA & Validation

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, 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.