QC Lab Systems Lead – LIMS, CDS & GMP Expert

Eli Lilly and Company; Pleasant Prairie (WI); Presencial; USD 66 000 - 154 000; Tempo integral

Resumo da oferta

Eli Lilly and Company’s Lilly Kenosha site in Pleasant Prairie, Wisconsin, is seeking a QC Lab Systems Analyst to deliver, integrate, and support LIMS, CDS, and instrument data systems in our Quality Control laboratories. You will lead system design, ensure compliance with 21 CFR Part 11, and drive continuous improvement with cross-functional teams while mentoring others at the P3 level.

This on-site, full-time role offers exposure to cutting-edge lab technology, SAP, MES integrations, and

Qualificações

• Bachelors in relevant field; GMP/21 CFR Part 11 knowledge.
• 5+ years implementing or supporting QC lab systems (LIMS/CDS).
• Hands-on experience with LabVantage, LabWare, Waters Empower, or Thermo Chromeleon.
• Understanding of data integrity and computer system validation.
• Strong QC lab process knowledge and analytical skills.

Responsabilidades

• Design, configure, implement, and maintain QC lab systems (LIMS/CDS).
• Translate lab requirements into system designs and master data.
• Lead integration of instruments with LIMS, CDS, and ERP/MES.
• Ensure compliance with 21 CFR Part 11 and data integrity.
• Own day-to-day lab system operations and incident management.
• Mentor team members and participate in inspections.

Conhecimentos

Analytical thinking

Problem-solving

Cross-functional collaboration

Communication skills

Agile/LEAN experience

Technical leadership

Formação académica

Bachelor's degree in Computer Science, Engineering, Chemistry, Life Sciences, or related field

Master's degree in Computer Science, Engineering, Chemistry, Life Sciences, or related field

Ferramentas

LabVantage

LabWare

Waters Empower

SQL

Python

ServiceNow

SAP S/4HANA

MES

Descrição da oferta de emprego

Eli Lilly and Company’s Lilly Kenosha site in Pleasant Prairie, Wisconsin, is seeking a QC Lab Systems Analyst to deliver, integrate, and support LIMS, CDS, and instrument data systems in our Quality Control laboratories. You will lead system design, ensure compliance with 21 CFR Part 11, and drive continuous improvement with cross-functional teams while mentoring others at the P3 level.

This on-site, full-time role offers exposure to cutting-edge lab technology, SAP, MES integrations, and