Senior Specialist LIMS

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! #J-18808-Ljbffr Hartmann Young