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Principal Consultant–Computer System Validation-Life Sciences, Infosys Consulting

Infosys Technologies

Infosys Technologies

IT Consulting

New York, NY - USA

Senior Specialist / Project Manager

Experteer Overview

In this Principal Consultant role, you drive IT Computerized System Validation (CSV) within Life Sciences to ensure compliant, high-quality validation deliverables. You lead and review lifecycle artifacts, guide teams on validation and security, and contribute to audits, while aligning with client SOPs and industry standards. You will shape validation strategy within Agile teams and help manage risk across multiple projects. This role offers a opportunity to influence large-scale validation programs and partner with cross-functional stakeholders to enable compliant, transformative outcomes.

Compensation / Benefits

  • Medical/Dental/Vision/Life Insurance
  • Long-term/Short-term Disability
  • Health and Dependent Care Reimbursement Accounts
  • 401(k) plan and contributions
  • Paid holidays and Paid Time Off

Responsibilities

  • Create, review, and approve validation deliverables
  • Define IT system development processes (build, test, deploy, monitor) following Agile methodologies and ensure release-level compliance
  • Author major project validation deliverables per client SOPs
  • Review and approve system lifecycle deliverables
  • Guide project teams on validation, security, and project management deliverables
  • Advise on compliance and security control implementation during development
  • Contribute to internal and external audits, assessments, or inspections
  • Escalate critical compliance findings and risks to appropriate client units
  • Prepare management reports on compliance operations and progress

Key requirements

  • 7+ years of Life Sciences experience in a consulting or industry setting
  • Strong understanding of 21 CFR Part 11, GxP, and GAMP 5
  • Experience creating, reviewing, and approving validation deliverables
  • Knowledge of risk management processes
  • Ability to support multiple projects in complex environments
  • IT background preferred to understand program complexities
  • Excellent communication and collaboration skills
  • Eligible to work in the US without visa sponsorship (Infosys cannot sponsor)

Description

In this Principal Consultant role, you drive IT Computerized System Validation (CSV) within Life Sciences to ensure compliant, high-quality …
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