Systems Validation Specialist

2 days ago

Delhi, Delhi, India beBeeValidator Full time ₹ 1,41,90,900 - ₹ 2,13,36,382

Job Overview

We are seeking a highly skilled Discoverant Validation Engineer to play a crucial role in ensuring that Biovia Discoverant implementations and enhancements meet regulatory compliance and validation standards.

The engineer will focus on Computer System Validation (CSV), documentation, risk assessment, testing, and quality assurance of Discoverant and related Biovia applications.

Key Responsibilities:

  • Lead and execute Computer System Validation (CSV) activities for Biovia Discoverant and integrated systems
  • Develop and maintain validation documentation (URS, FS, DS, Risk Assessments, IQ, OQ, PQ, Traceability Matrix, Validation Plan/Report)
  • Ensure validation strategies align with GAMP 5 guidelines, 21 CFR Part 11, and Annex 11
  • Collaborate with cross-functional teams (IT, QA, Business, Vendors) for validation planning and execution
  • Support audits and inspections by providing validation evidence and documentation
  • Perform impact assessments for system changes and revalidation requirements
  • Maintain audit trail and configuration control in a compliant manner
  • Support testing efforts including writing test scripts and managing deviations
  • Provide training and knowledge transfer on validated systems to business and IT users

Required Skills:

  • Strong experience in validating Biovia Discoverant in a GxP-regulated environment
  • In-depth knowledge of Computer System Validation (CSV) lifecycle
  • Familiarity with GAMP 5, 21 CFR Part 11, EU Annex 11 compliance frameworks
  • Excellent documentation skills (URS, IQ/OQ/PQ, Validation Plans/Reports)
  • Understanding of manufacturing and quality processes in the pharmaceutical industry
  • Hands-on experience in managing validation activities through tools like HP ALM, Veeva Vault QMS, or similar platforms
  • Strong analytical and problem-solving skills

Personal Attributes:

  • Detail-oriented and methodical approach to validation
  • Excellent communication and documentation skills
  • Collaborative team player with ability to engage multiple stakeholders
  • Strong time-management and multi-tasking abilities
  • Ability to work independently with minimal supervision
  • Quality and compliance mindset
  • Proactive attitude in identifying validation risks and proposing mitigations

Work Environment:

US-based position

Flexible work schedule can be arranged

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