Job Description

Key Responsibilities

  • Plan, coordinate and execute full lifecycle validation of computerized systems, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification)
  • Develop and maintain validation deliverables: plans, protocols, test scripts, traceability matrices, summary reports
  • Conduct system risk assessments, create and review URS (User Requirements Specification), functional specifications, and design documentation
  • Ensure regulatory compliance with frameworks such as FDA 21 CFR Part 11, GAMP 5, EU Annex 11, ISO 13485, IEC 62304, GLP/GMP/GCP as applicable
  • Collaborate with IT, QA, R&D, and business units to manage change controls, deviations, and re-validation efforts
  • Prepare documentation for and support internal/external audits and inspections; address regulatory inquiries
  • Conduct periodic system reviews and decommissioning/retirement activities as needed
  • Provide training to stakeholders on validated systems and compliance practices


Qualifications & Experience

  • Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field
  • 2–5+ years experience in computer system validation within regulated industries (medical devices, pharmaceuticals, biotech)
  • Familiarity with validation methodologies: risk-based validation, GAMP 5, and SDLC
  • Strong knowledge of data integrity principles and project management tools
  • Excellent written and verbal communication abilities; strong analytical and documentation skills
  • Experience integrating and validating systems like ERP, LIMS, MES, LabX, UV‑Vis, FTIR, or similar is a plus
  • Professional certifications (ASQ, ISPE, etc.) are advantageous


Regulatory & Technical Knowledge

  • Deep understanding of FDA CFR Title 21, EU Annex 11, ISO 13485, IEC 62304, GLP/GMP/GCP, and GxP principles
  • Awareness of medicinal and medical device regulatory standards and industry best practices


Preferred Attributes

  • Strong organizational skills with attention to detail
  • Ability to work collaboratively in cross-functional teams
  • Experience with audit readiness and remediation activities
  • Desire for continuous improvement and staying current with regulatory trends

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