About the role:
We are looking for a Senior ELN / SDMS Consultant with strong hands‑on experience in NuGenesis SDMS to support a global life sciences client in a regulated (GxP) environment.
This role focuses on system validation, production support, and compliance, working closely with IT, Business, and Quality teams to ensure data integrity and regulatory readiness.
What you will do
- Validate NuGenesis SDMS in line with GxP, FDA 21 CFR Part 11, and EU Annex 11 requirements
- Configure and maintain File Captures in NuGenesis based on client needs
- Provide technical support and troubleshooting to ensure system stability
- Handle Incidents and support L2/L3 issues through Problem Management
- Support audits and inspections by regulatory authorities and internal QA teams
- Participate in implementation, migration, and deployment activities
- Assist with IQ / OQ / PQ validation protocols and documentation
- Collaborate with IT, Business, and Quality stakeholders to maintain system integrity
What we are looking for:
Mandatory
- 3+ years of hands‑on experience with NuGenesis SDMS
- Experience in Life Sciences / Pharma environments
- Strong understanding of GxP compliance and system validation
- Experience supporting regulated systems in production
- Good communication skills in a remote / global setup
- Strong ownership and attention to detail
Nice to have
- Experience with audits and inspections
- Exposure to ELN/SDMS implementations or migrations
Why join:
- Senior role in a regulated, high‑impact environment
- Work on critical scientific data systems
- International exposure and long‑term project potential
- Opportunity to deepen expertise in ELN / SDMS validation
Benefits Cognizant:
- Be Well program - Designed with flexibility in mind to meet the diverse needs of each associate, provides the physical, mental and financial support needed to navigate life and work. Here are a few highlights of the program:
- Physical and mental wellbeing – Access to benefits and programs that support your physical and mental health
- Private Medical Subscription or Insurance
- Life insurance
- Employee Assistance Program – a variety of mental wellbeing resources designed to support you on your mental health journey
- Life & Work culture – Benefits that empower you to make time for yourself and the things that matter at work and outside of it
- Annual leave – 22 working days
- Professional development - trainings, workshops, certifications - we facilitate access to high quality training programs and certifications on both technical and soft-skills areas, aligned with business needs and personal goals
CogHR107
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