LIMS and Data Systems Specialist

The businesses of Merck KGaA, Darmstadt, Germany•St. Louis, MO

About The Position

Your Role: Responsibilities include but are not limited to: Create, review, and approve product and master builds in LIMS and OT systems in compliance with 21 CFR Part 11 and EU Annex 11, ensuring data integrity and regulatory compliance. Review, update, and maintain supporting documentation for new and revised product and master builds. Initiate, manage, and execute Change Controls for LIMS and other OT systems. Serve as a subject matter expert (SME), providing advanced troubleshooting and support for live production systems. Maintain systems in a validated and controlled state to ensure ongoing operational readiness. Own LIMS SOPs, work instructions, and training materials; deliver end-user and technical training and act as a technical consultant. Author URS documents and support system qualification activities, including execution of internal qualification protocols. Perform data integrity and audit trail risk assessments, support deviation investigations and root cause analysis, and lead cross-functional projects from initiation through completion.

Requirements

Bachelor’s Degree in Chemistry, Biology or other Life Science discipline OR Chemical Engineering, Mechanical Engineering, or other Engineering discipline and 2+ years of experience.
OR Associate’s Degree in Chemistry, Biology or other Life Science discipline OR Chemical Engineering, Mechanical Engineering, or other Engineering discipline and 5+ years of experience.
1+ years of LabVantage LIMS, TrackWise and/or Veeva experience.

Nice To Haves

Experience with instruments, such as HPLC, GC, LCMS, CGE, AA, TOC, FTIR, KF, iCE.
Experience with wet chemistry.
Experience with general laboratory instrumentation and troubleshooting.
Experience with prior instrumentation qualification.
Experience in a team setting in a dynamic environment where shifting priorities are not uncommon.
Excellent communication skills, both oral and written.
Experience collaborating across teams and departments to establish new processes and system integration projects.

Responsibilities

Create, review, and approve product and master builds in LIMS and OT systems in compliance with 21 CFR Part 11 and EU Annex 11, ensuring data integrity and regulatory compliance.
Review, update, and maintain supporting documentation for new and revised product and master builds.
Initiate, manage, and execute Change Controls for LIMS and other OT systems.
Serve as a subject matter expert (SME), providing advanced troubleshooting and support for live production systems.
Maintain systems in a validated and controlled state to ensure ongoing operational readiness.
Own LIMS SOPs, work instructions, and training materials; deliver end-user and technical training and act as a technical consultant.
Author URS documents and support system qualification activities, including execution of internal qualification protocols.
Perform data integrity and audit trail risk assessments, support deviation investigations and root cause analysis, and lead cross-functional projects from initiation through completion.