LIMS and Data Systems Specialist
Merck Group - St Louis, MO
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Work Location: St. Louis, Missouri Shift: No Department: LS-SC-UYKN Cherokee STL Engineering Recruiter: Kathy Lewison This information is for internals only. Please do not share outside of the organization.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. Minimum Qualifications: 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. Preferred Qualifications: 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. Pay Range for this position: $76,200/yr-$114,200/yr The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here. The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
Created: 2026-03-04