Senior GxP IT Lab Systems Lead

Default (MSD); Rockville (MD); Híbrido; USD 117.000 - 178.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health benefits

Descripción de la vacante

MSD in Rockville, MD seeks a Senior Information Technology GxP Technical Analyst to lead design and validation of IT solutions for the Bioanalytical Laboratory. You will own technical standards, roadmaps, and end-to-end delivery of GxP systems including LIMS, instrument interfaces, and electronic records.

You will collaborate with QA, Cybersecurity, and scientists to ensure inspection readiness and 21 CFR Part 11 compliance, while mentoring staff in validated delivery practices.

Formación

• Bachelor’s degree in IT, CS, IS or related field.
• Minimum 6 years designing or implementing computerized systems.
• 3+ years in a GLP/GCLP regulated environment.
• Experience with validated SDLC and IQ/OQ/PQ testing.

Responsabilidades

• Act as senior technical authority for Bioanalytical Lab systems and roadmaps.
• Gather and document requirements; translate to functional designs.
• Design, configure, deploy LIMS and instrument data interfaces.
• Lead system lifecycle tasks: environments, version control, testing.
• Produce inspection-ready validation documentation for QA.
• Manage change controls and validated release pathways.
• Lead complex multi-system initiatives end to end.

Conocimientos

GxP compliance

SQL

APIs

Web services

IQ/OQ/PQ

SDLC

LabWare

LabVantage

LIMS

Documentation

Educación

Bachelor's degree in IT/CS/IS

Herramientas

LabWare

LabVantage

STARLIMS

Watson LIMS

Descripción del empleo

MSD in Rockville, MD seeks a Senior Information Technology GxP Technical Analyst to lead design and validation of IT solutions for the Bioanalytical Laboratory. You will own technical standards, roadmaps, and end-to-end delivery of GxP systems including LIMS, instrument interfaces, and electronic records.

You will collaborate with QA, Cybersecurity, and scientists to ensure inspection readiness and 21 CFR Part 11 compliance, while mentoring staff in validated delivery practices.