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

Bachelors degree in Computer Science, Engineering, Life Sciences, or related field
25+ 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, UVVis, 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

Validation Engineer ( Medical Device Domain)