Testing & Computer System Validation (CSV) Specialist - HYBRID

JOB DESCRIPTION

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).

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.

Minimum Requirements

Preferred Skills :

#LI-NorthAmerica

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.