CrawlJobs Logo

Testing & Computer System Validation Specialist

Canada, Ottawa · Job Posted February 18, 2026
Apply Position
Job Link Share

Job Description

The Testing & Computer System Validation Specialist role involves ensuring compliance with regulatory standards in the Healthcare sector. Candidates should have 5-8 years of experience in Computer System Validation, particularly in IQ, OQ, and PQ activities. A bachelor's degree in Engineering, Computer Science, or Life Sciences is required. Strong documentation and analytical skills are essential for success in this position.

Job Responsibility

  • 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

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

Nice to have

  • Solid understanding of SDLC, STLC, and risk-based validation approaches
  • Exposure to automation testing tools or test management tools is an added advantage
  • Prior experience working in regulated environments with global clients

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Similar Jobs for

Testing & Computer System Validation Specialist

8 matching positions

Testing & Computer System Validation (CSV) Specialist - Healthcare

We are seeking an experienced Testing & Computer System Validation (CSV) Special...
Location
Location
Canada , Ottawa
Salary
Salary:
Not provided
nttdata.com Logo
NTT DATA
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 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
Job Responsibility
Job Responsibility
  • 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
  • Fulltime
Read More
Arrow Right

Testing & Computer System Validation (CSV) Specialist – Healthcare

We are seeking an experienced Testing & Computer System Validation (CSV) Special...
Location
Location
Mexico , Guadalajara
Salary
Salary:
Not provided
nttdata.com Logo
NTT DATA
Expiration Date
Until further notice
Flip Icon
Requirements
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
  • 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
Job Responsibility
Job Responsibility
  • 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
Read More
Arrow Right

Computer Specialist

Summary: Installs, modifies, and makes repairs to personal computer hardware and...
Location
Location
United States , Vicksburg
Salary
Salary:
Not provided
mmlonline.com Logo
Mississippi Municipal League
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Associate's degree (A. A.) or equivalent from two-year college or technical school
  • or six months to one year related experience and/or training
  • or equivalent combination of education and experience
  • Must have a valid driver's license
  • Knowledge of Microsoft Office Suite
  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals
  • Ability to write routine reports and correspondence
  • Ability to speak effectively before groups of customers or employees of organization
  • Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals
  • Ability to compute rate, ratio, and percent and to draw and interpret bar graphs
Job Responsibility
Job Responsibility
  • Installs, modifies, and makes repairs to personal computer hardware and software systems
  • Provides technical assistance and training to system users
  • Provides users with network technical support fast and courteously
  • Responds to needs and questions of users concerning their access of network resources
  • Installs and tests necessary software and hardware
  • Installs or assists outside service personnel in installation of hardware and peripheral components such as monitors, keyboards, printers and disk drives
  • Loads specified software packages such as operating systems, word processing, or spreadsheet programs into computers
  • Enters commands and observes system functions to verify correct system operation
  • Respond to end-user inquiries concerning systems operation and diagnosis system hardware, software, and operator problems
  • Instruct and train users in use of equipment, software, and manuals
  • Fulltime
Read More
Arrow Right

Senior System Specialist

We are seeking a high‑performing, self‑driven Senior System Specialist/Engineer ...
Location
Location
Canada , Markham
Salary
Salary:
115000.00 - 164600.00 USD / Year
gm.com Logo
General Motors
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Strong knowledge of systems and software architecture, embedded software development, and testing methodologies
  • 5+ years of experience in systems engineering, embedded software, EV charging, infotainment, or a related development domain
  • Bachelor’s degree in Electrical, Computer, Software, Mechatronics Engineering, or a related field
  • Experience with requirements tools such as DOORS/DNG and Rhapsody (preferred)
  • Familiarity with Agile or SAFe development methodologies
  • Understanding of CI/CD automation and continuous testing strategies
  • Experience with Service‑Oriented Architecture (SOA) and Behavior‑Driven Development (BDD)
  • Strong analytical and problem‑solving skills, with the ability to navigate complex technical challenges
  • Excellent written and verbal communication skills
  • Strong interpersonal skills and ability to collaborate across global teams and functional areas
Job Responsibility
Job Responsibility
  • Contribute to the development of system and solution requirements for charging user experience
  • Support the definition and management of system and solution requirements, interfaces, states, and performance targets within infotainment and compute‑oriented systems
  • Participate in the decomposition and allocation of product, feature, and system functionality to software and compute platform teams
  • Collaborate with cross‑functional partners including software engineering, validation, UX, mobile, and Cloud Services
  • Assist in issue triage, root‑cause analysis, and resolution during development and testing phases
  • Support continuous improvement activities and help enhance system robustness and user experience
  • Document system deliverables, maintain requirement traceability, and support program milestones and readiness reviews
What we offer
What we offer
  • Paid time off including vacation days, holidays, and supplemental benefits for pregnancy, parental and adoption leave
  • Healthcare, dental and vision benefits including health care spending account and wellness incentive
  • Life insurance plans to cover you and your family
  • Company and matching contributions to a Defined Contribution Pension plan to help you save for retirement
  • GM Vehicle Purchase Plan for you, your family, and friends
  • Fulltime
Read More
Arrow Right

Verification and Validation Specialist

In this position, the incumbent plays a crucial role in the product development ...
Location
Location
Canada , Montreal
Salary
Salary:
Not provided
spacebridge.com Logo
SpaceBridge Inc.
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s Degree in Networking, Telecommunication, Electronics, Computer, or IT engineering
  • Minimum 2 years’ experience in a verification and validation role
  • Strong Lab R&D with equipment Integration capabilities
  • Familiar with R&D concepts and capable of working with test tools and in a lab environment
  • Self-motivated, self-trained, and enthusiastic for research and invention, who can work with minimal supervision
  • Strong technical writing and presentation skills
  • Good interpersonal and communication skills in English
  • Familiar working in an agile environment and with software project management tools (Jira)
  • Solid experience in test automation and continuous integration
  • Solid experience in functional and performance testing
Job Responsibility
Job Responsibility
  • Interact with the system, software, and hardware development teams, product owners, and other stakeholders to develop a strong understanding of the product and the testing objectives
  • Implement and lead the testing strategy/planning (integration, functional, performance)
  • Design and document test plans, test procedures, test cases, and the verification matrix as required by the project
  • Provide clear and concise test reports for product releases and as required
  • Design and maintain the testing environment
  • Develop and run automated scripts for both functionality and performance testing of the product(s), and to help the development teams in their efforts
  • Participate in design reviews and ensure design requirements are testable
  • Actively participate in team progress meetings (such as scrum) and provide systems and testing-related feedback to guide the development
  • Provide assistance to the development teams for their lab setups
  • Troubleshoot test failures, analyze root causes and assist the development team to help them fix the issues
  • Fulltime
Read More
Arrow Right

Csv Specialist / Csv Consultant - Mes Validation

Location
Location
India , Hyderabad
Salary
Salary:
Not provided
nttdata.com Logo
NTT DATA
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 5+ years of experience in Computer System Validation (CSV)
  • 3 to 5 years of experience in pharmaceutical, biotech, life sciences, or regulated manufacturing environments
  • 3+ years of hands-on experience with MES validation and GxP validation lifecycle
  • Good understanding of 21 CFR Part 11, EU Annex 11, ALCOA+, and data integrity expectations
  • Experience in validation document preparation, review, execution, and approval workflows
  • Ability to coordinate with QA, Manufacturing, IT, Automation, and vendor teams
  • Strong documentation discipline and attention to detail
Job Responsibility
Job Responsibility
  • Validation Plan and Validation Risk Assessment
  • Requirement Traceability Matrix
  • IQ, OQ, and PQ protocols
  • Executed test scripts with objective evidence
  • Deviation, defect, and issue logs with closure evidence
  • Validation Summary Report
  • Approved validation package supporting MES go-live readiness
  • Fulltime
Read More
Arrow Right

CSV Specialist / CSV Consultant - MES Validation

We are looking for experienced CSV resources to support a Manufacturing Executio...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
nttdata.com Logo
NTT DATA
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 5+ years of experience in Computer System Validation (CSV)
  • 3 to 5 years of experience in pharmaceutical, biotech, life sciences, or regulated manufacturing environments
  • 3+ years of hands-on experience with MES validation and GxP validation lifecycle
  • Good understanding of 21 CFR Part 11, EU Annex 11, ALCOA+, and data integrity expectations
  • Experience in validation document preparation, review, execution, and approval workflows
  • Ability to coordinate with QA, Manufacturing, IT, Automation, and vendor teams
  • Strong documentation discipline and attention to detail
Job Responsibility
Job Responsibility
  • Support validation planning, impact assessment, risk assessment, and validation strategy for the MES scope
  • Prepare and review validation documents such as Validation Plan, URS, FRS, DS, RTM, IQ, OQ, PQ, and Validation Summary Report
  • Prepare, review, and execute validation test scripts with objective evidence as per approved procedures
  • Log, track, investigate, and support closure of deviations, defects, and validation observations
  • Validate MES workflows, master data, recipes, electronic batch records, equipment integration, interfaces, and user roles
  • Ensure alignment with GxP, 21 CFR Part 11, EU Annex 11, ALCOA+, data integrity, and internal quality standards
  • Maintain end-to-end traceability from requirements to testing and final validation closure
  • Work closely with MES functional team, technical team, QA, manufacturing SMEs, automation, and business users
  • Ensure validation deliverables are complete, controlled, and inspection-ready
  • Fulltime
Read More
Arrow Right
New

Applications Development Tech Lead Analyst

Citibank, N.A. seeks an Applications Development Tech Lead Analyst for its Tampa...
Location
Location
United States , Tampa
Salary
Salary:
164000.00 - 171360.00 USD / Year
https://www.citi.com/ Logo
Citi
Expiration Date
August 11, 2026
Flip Icon
Requirements
Requirements
  • Bachelor’s degree, or foreign equivalent, in Computer Engineering, Information Technology, Computer Science or related field and 6 years of progressive, post-baccalaureate experience as a Software Engineer, Senior Specialist Data Engineering, Tableau Developer, Technical Support, IT Analyst or related position developing Tableau reports and dashboards for financial applications
  • 6 years of experience must include: Tableau Desktop and Tableau Server
  • Oracle, DB2, Informatica, Autosys, UNIX Scripting
  • Creating and documenting standard operating procedures for enterprise monitoring
  • 5 years of experience must include: SQL and Database Management Systems
  • Python and ETL
Job Responsibility
Job Responsibility
  • Responsible for advanced data visualization, dashboard development, and analytical reporting utilizing Tableau Desktop and Server
  • Create reports using BI Tools and Python development, specifically for automating the ingestion and processing of data from various feeds and APIs into PostgreSQL databases
  • comprehensive preparation and timely delivery of critical monthly and quarterly business reports
  • Partner with multiple management teams to ensure the appropriate integration of functions by creating reports using Tableau Reporting tool and data transformation using SQL Server and Python
  • Identify and define necessary systems needed to show the reports for the PM Community by automating the manual effort and tracking down the changes on daily needs
  • Resolve a variety of high impact problems and projects through in-depth evaluation of complex business processes, system processes, and industry standards
  • Develop standards for coding, testing, debugging, and implementation for software applications
  • Ensure that application designs adhere to the overall architecture of reporting needs on PM related activities using the automated approach of loading the files and showing it on a Tableau Report
  • Design, develop, and modify software systems, using scientific analysis and mathematical models to predict and measure outcomes and consequences of design
  • Determine system performance standards
What we offer
What we offer
  • medical, dental & vision coverage
  • 401(k)
  • life, accident, and disability insurance
  • wellness programs
  • paid time off packages, including planned time off (vacation), unplanned time off (sick leave), and paid holidays
  • Fulltime
Read More
Arrow Right