ITSoli - NuGenesis SDMS System Administrator

Description : NuGenesis SDMS System Administrator (File Capture / Print Capture)

Qualification : Bachelors degree in computer science, Information Technology, Life Sciences, or related field.

Experience :

Minimum 2+ years hands-on NuGenesis SDMS administration with strong expertise in either/both (File Capture / Print Capture) modules and seamless integration with laboratory workflows.

Work Timing :

US (PST) Hours (Work schedule can be split into 4 hours PM (IST) and 4 hours AM (PST) working hours once KT (Knowledge Transfer) days are completed for new Joiners - depending on daylight saving)

Client Brief :

A pioneering biopharmaceutical leader, the client organization is driven by a mission to discover, develop, and deliver transformative therapies that improve the lives of people around the world. With a deep focus on innovation, they have introduced groundbreaking treatments across areas such as virology, oncology, and inflammation. Their trailblazing work has contributed to global advancements in HIV treatment and the fight against viral diseases. Recognized for a robust pipeline and a legacy of scientific excellence, they continuously invest in cutting-edge research and strategic partnerships. Their commitment to access, sustainability, and patient-centric innovation has earned them accolades as one of the most admired and socially responsible companies in the healthcare industry.

Job Role :

We are seeking a skilled NuGenesis SDMS System Administrator with proven expertise in either/both (File Capture or Print Capture) workflows for a leading US-based biopharmaceutical organization. The role involves configuring, administering, and supporting the Scientific Data Management System in a regulated (GxP) environment, ensuring data integrity, compliance with 21 CFR Part 11, and seamless integration with laboratory workflows. The professional will collaborate with global cross-functional teams, provide end-user support, and participate in validation, upgrades, and harmonization initiatives to maintain system reliability and regulatory readiness.

Key Responsibilities :

- Administer and maintain NuGenesis SDMS, including File Capture and Print Capture modules.

- Configure capture routes, templates, workflows, and user roles/permissions.

- Provide technical support and training to laboratory and business users.

- Monitor system performance, troubleshoot issues, and resolve capture failures.

- Ensure compliance with GxP, 21 CFR Part 11, and Data Integrity standards.

- Maintain SOPs, Work Instructions, and validation documentation (IQ/OQ/PQ).

- Perform system upgrades, patches, backups, and ensure disaster recovery readiness.

- Collaborate with CSV, QA, and Laboratory teams for validation and audits.

- Participate in global or cross-site NuGenesis SDMS deployment and harmonization.

- Support integration with LIMS, ELN, or other laboratory systems.

Required Skills :

- Hands-on experience with NuGenesis SDMS - any (File Capture, Print Capture).

- Strong knowledge of Windows Server OS, IIS, and SQL Server configuration/maintenance.

- Expertise in GxP, 21 CFR Part 11, and Data Integrity principles.

- Experience configuring print templates, file capture routes, and workflow automation.

- Strong problem-solving and troubleshooting skills in validated systems.

- User access and security management experience in regulated environments.

Desired Skills :

- Scripting knowledge (PowerShell, VBScript, or similar).

- Experience integrating SDMS with LIMS/ELN systems.

- Familiarity with Change Control, Incident Management, and Validation Lifecycle.

- Knowledge of Documentum or other ECM systems.

- Prior experience in pharmaceutical or biotech environments.

Personal Attributes :

- Strong attention to detail and documentation discipline.

- Excellent communication and collaboration skills.

- Ability to work independently under minimal supervision.

- Proactive, analytical, and solution-oriented mindset.

- Quality-conscious and compliance-driven.

- Willingness to work flexible hours across time zones.