LIMS and Data Systems Specialist

Merck • Saint Louis, MO

2d

About The Position

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your Role:

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.

Benefits

• Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.
• For more information click here

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level