CSV Analyst

I.T. Solutions, Inc.
Belmont, United States of America
yesterday

Role details

Contract type
Temporary contract
Employment type
Full-time (> 32 hours)
Working hours
Regular working hours
Languages
English
Experience level
Senior

Job location

Belmont, United States of America

Tech stack

Amazon Web Services (AWS)
JIRA
Azure
Business Software
Business Systems
Cloud Computing
Data Mapping
Disaster Recovery
Monitoring of Systems
Identity and Access Management
Microsoft Visio
Scrum
SAP Applications
Server Administration
System Testing
Software Vulnerability Management
Reliability of Systems
Information Technology
Tools for Reporting
Veeva
GXP

Job description

This role is responsible for system administration, validation, and operational support within a life sciences environment to ensure compliant, reliable, and efficient systems. Responsibilities include leading validation activities (authoring, execution, and review of protocols), project management and administering both GxP and business applications.

  • Key Responsibilities: Provide operational and maintenance support for GxP and business applications, including incident resolution, access management, and job monitoring to ensure system reliability
  • Lead and execute validation activities (CSV lifecycle), including protocol authoring, review, execution, and audit readiness using ValGenesis
  • Manage quality events (Change Control, Deviations, CAPA) in Quality Management System to ensure compliance with GxP and regulatory requirements
  • Perform periodic maintenance activities for GxP and business systems, including SATR, server maintenance, backup/restore testing, and disaster recovery (DR) validation
  • Manage infrastructure lifecycle, including server upgrades, decommissioning, and cloud (AWS) resource optimization
  • Drive security and vulnerability management, ensuring timely patching and remediation across systems
  • Support system migrations and enhancements, including data mapping, validation, and on-prem to cloud transitions
  • Lead Agile/Scrum activities, including facilitating daily stand-ups, managing sprint tasks, and tracking team deliverables using tools such as JIRA/Azure DevOps
  • Participate in SQA testing and continuous improvement initiatives to enhance system performance and efficiency
  • Maintain dashboards and reports to monitor system performance and provide actionable insights
  • Conduct GxP system instructor-led training and engage stakeholders to ensure effective system usage, compliance, and adoption
  • Coordinate with cross-functional teams to prioritize work, manage dependencies, and drive operational excellence

Requirements

Bachelor's degree in Computer Science, Information Technology, or related discipline

  • 8+ years of relevant experience
  • Demonstrated experience in GxP system administration and Computer System Validation (CSV)
  • Expertise in Server and infrastructure management, including backup/restore and disaster recovery
  • Expertise in Cloud platforms (AWS/Azure) and enterprise IT environments
  • Hands-on experience with validation and quality systems (ValGenesis or equivalent, Veeva QMS)
  • Proficiency with project and reporting tools, including Azure DevOps, JIRA, MS Visio
  • Nice to Have: Exposure to SAP ecosystems
  • Experience with automation and process optimization (RPA)

The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.

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