Senior ELN/SDMS Consultant – NuGenesis (GxP)

About the role

We are seeking a Senior ELN/SDMS Consultant to lead validation and production support of NuGenesis SDMS for a global life‑sciences client operating in a regulated GxP environment. You will work closely with IT, business, and quality teams to ensure data integrity and regulatory compliance.

Key responsibilities

• Validate NuGenesis SDMS against GxP, FDA 21 CFR Part 11 and EU Annex 11 requirements.
• Configure and maintain file captures according to client specifications.
• Provide L2/L3 technical support, incident handling and problem management.
• Support audits, inspections and internal QA reviews.
• Participate in implementation, migration and deployment projects.
• Assist with IQ, OQ and PQ validation protocols and documentation.

Required profile

• Minimum 3 years hands‑on experience with NuGenesis SDMS.
• Background in life‑sciences or pharmaceutical environments.
• Strong understanding of GxP compliance and system validation.
• Experience supporting regulated systems in production.
• Effective communication in a remote/global setting.

Required skills

• NuGenesis SDMS
• GxP compliance
• FDA 21 CFR Part 11
• EU Annex 11
• IQ/OQ/PQ validation
• L2/L3 support
• Problem Management

What we offer

• Senior role in a high‑impact, regulated environment.
• International exposure and long‑term project potential.
• Comprehensive wellbeing program, private medical coverage, life insurance and 22 days of annual leave.
• Professional development through trainings, workshops and certifications.