Validation engineer • ottawa on
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Req ID: 356805
We are currently seeking a Testing & Computer System Validation (CSV) Specialist - HYBRID to join our team in Ottawa, Ontario (CA-ON), Canada (CA).
Job Title: Testing & Computer System Validation (CSV) Specialist – Healthcare
Experience: 8+ Years
Domain: Healthcare / Life Sciences
Job Summary
We are seeking an experienced Testing & Computer System Validation (CSV) Specialist with strong expertise in IQ, OQ, and PQ activities within the Healthcare / Life Sciences domain. The ideal candidate will ensure that computerized systems are validated and compliant with regulatory standards, supporting quality, safety, and data integrity across regulated environments.
Key Responsibilities
Plan, execute, and document Computer System Validation (CSV) activities in compliance with regulatory requirements (GxP, FDA, EMA, etc.).
Develop and review validation deliverables including Validation Plans, Risk Assessments, IQ, OQ, PQ protocols, Traceability Matrices, and Validation Summary Reports.
Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for computerized systems.
Execute manual and automated testing activities aligned with validation requirements.
Ensure compliance with 21 CFR Part 11, GAMP 5, and data integrity principles (ALCOA+).
Collaborate with cross-functional teams including Quality, IT, Business, and Vendors.
Support audits and inspections by preparing validation evidence and responding to audit queries.
Participate in change control, deviation management, CAPA, and periodic reviews of validated systems.
Provide guidance and mentorship to junior validation/test team members as needed.
Required Skills & Experience
8+ years of hands-on experience in Testing and Computer System Validation within the Healthcare / Life Sciences domain.
5+ years of strong practical experience with IQ, OQ, and PQ execution.
5+ years of in-depth knowledge of CSV methodologies and regulatory standards (FDA, GxP, GAMP 5).
5+ years of experience validating systems such as LIMS, QMS, ERP, EMR, or Clinical systems is a plus.
Solid understanding of SDLC, STLC, and risk-based validation approaches.
Excellent documentation, analytical, and communication skills.
Ability to work independently and manage multiple validation activities simultaneously.
Preferred Qualifications
Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field.
Exposure to automation testing tools or test management tools is an added advantage.
Prior experience working in regulated environments with global clients.
About NTT DATA
NTT DATA is a $30 billion business and technology services leader, serving 75% of the Fortune Global 100. We are committed to accelerating client success and positively impacting society through responsible innovation. We are one of the world's leading AI and digital infrastructure providers, with unmatched capabilities in enterprise-scale AI, cloud, security, connectivity, data centers and application services. our consulting and Industry solutions help organizations and society move confidently and sustainably into the digital future. As a Global Top Employer, we have experts in more than 50 countries. We also offer clients access to a robust ecosystem of innovation centers as well as established and start-up partners. NTT DATA is a part of NTT Group, which invests over $3 billion each year in R&D.
