Testing & Computer System Validation (CSV) Specialist - HYBRID

Req ID: 356805 NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. 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

• 5–8 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.
• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field.

Preferred Skills:

• 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.
• 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. Whenever possible, we hire locally to NTT DATA offices or client sites. This ensures we can provide timely and effective support tailored to each client’s needs. While many positions offer remote or hybrid work options, these arrangements are subject to change based on client requirements. For employees near an NTT DATA office or client site, in-office attendance may be required for meetings or events, depending on business needs. At NTT DATA, we are committed to staying flexible and meeting the evolving needs of both our clients and employees. NTT DATA recruiters will never ask for payment or banking information and will only use @nttdata.com and @talent.nttdataservices.com email addresses. If you are requested to provide payment or disclose banking information, please submit a contact us form, https://us.nttdata.com/en/contact-us. NTT DATA endeavors to make https://us.nttdata.com accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact us at https://us.nttdata.com/en/contact-us.__This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. NTT DATA is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. For our EEO Policy Statement, please click here. If you'd like more information on your EEO rights under the law, please click here. For Pay Transparency information, please click here.