Related skills
data integrity system validation gxp lims eln📋 Description
- Lead ELN/LIMS platforms as system owner.
- Implement and maintain ELN/LIMS in GxP CRO env.
- Ensure data integrity, security, and audit trails per 21 CFR Part 11.
- Collaborate with lab leadership, QA, IT to design systems.
- Drive continuous improvement to streamline workflows.
- Oversee validation planning, execution, and change control.
🎯 Requirements
- Bachelor’s degree in science/technical field required.
- Advanced degree or certifications preferred.
- 5+ years ELN/LIMS experience in regulated lab.
- Experience in pharma/CRO/regulatory env.
- Experience with validation, change control, regulatory compliance.
- Strong understanding of lab workflows and data lifecycle.
- Experience managing cross-functional projects with technical and scientific stakeholders.
🎁 Benefits
- Company-sponsored events and activities.
- Career growth through KCAS University.
- Wellness, inclusion, and community programs.
- Stock ownership program.
- Access to latest technology.
- Volunteer paid time off.
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