[All remote jobs](https://jobicy.com/jobs.md)[![Alimentiv logo](https://jobicy.com/data/server-nyc0409/galaxy/mercury/2025/06/d11f5845-221.png)](https://jobicy.com/company/alimentiv.md)[Alimentiv](https://jobicy.com/company/alimentiv.md) # GCP – Computer System Validation Specialist (12 month limited-term) AI Summary Alimentiv is seeking a Computer System Validation Specialist for a 12-month limited-term role supporting GCP-regulated computerized systems. The specialist will plan and execute CSV activities, create validation documentation, coordinate testing, and manage defects, deviations, and change control. The role requires close collaboration with IT, Quality Assurance, business stakeholders, and external vendors within regulated clinical-research environments. Candidates need 3–5 years of relevant experience and practical knowledge of GxP, 21 CFR Part 11, SDLC processes, and audit-ready documentation. This is a full-time remote Canadian role with an explicitly supplied annual CAD salary range.[Apply for this job](#job-application)[View company](https://jobicy.com/company/alimentiv.md)ShareRemote from[Canada](https://jobicy.com/job-region/canada.md)SalaryCAD 69k–115k / yrDepartment[QA & Testing](https://jobicy.com/categories/qa-testing.md)EmploymentFull TimeExperienceSeniorPublished6 Nov 2026Apply before6 Dec 2026Listing views39Application actions3Application toolkit ## Make your next move. Prepare your resume, explore your fit, and draft a cover letter for this opportunity. Opportunity details ## About this role. Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development. We operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there. If you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you! Looking for a new challenge with real impact, ensuring technology meets the highest quality and compliance standards in a regulated environment? As a Computer System Validation (CSV) Specialist, you will play a key role in validating GCP-regulated systems, partnering with IT, Quality, and business teams to deliver compliant, reliable solutions. You’ll lead validation activities from planning through execution, influence system quality and integrity, and help drive continuous compliance with industry regulations and best practices. ### About the Role: * Execute validation activities for computerized systems and software in compliance with GxP, 21 CFR Part 11, and applicable regulatory requirements. * Develop and maintain validation documentation, including validation plans, test scripts, traceability matrices, summary reports, and release documentation. * Partner with IT, Quality Assurance, business stakeholders, and external vendors to define validation strategies and ensure successful project delivery. * Coordinate and oversee validation testing activities, ensuring requirements are appropriately tested and documented. * Manage defects, deviations, and incidents identified during testing, including triage, resolution tracking, and closure documentation. * Facilitate review, approval, execution, and post-execution management of validation and qualification documentation. * Train and support project teams on validation procedures, tools, documentation standards, and best practices. * Provide ongoing guidance on change management for validated systems and stay current with evolving regulatory requirements and industry standards. ### What we’re looking for: * ### Qualifications Bachelor’s degree in Computer Science, Information Technology, Engineering, Software Development, or a related field with 3-5 years of relevant experience, or equivalent combination of education and experience. * Experience validating GCP-regulated computerized systems and software, ideally within the pharmaceutical, biotechnology, medical device, or other highly regulated industries. * Strong understanding of quality system principles, including validation, documentation, change control, training, and audit readiness. * Proven ability to collaborate effectively in cross-functional and matrixed environments, building strong relationships with internal stakeholders, business partners, and external vendors. * Excellent written and verbal communication skills, with the ability to clearly document, present, and explain technical and compliance-related information. * Experience working within Software Development Lifecycle (SDLC) processes; familiarity with automated testing tools and enterprise validation technologies is considered an asset. ### What We Offer In addition, as an Alimentiv Employee, you’re also eligible for the following programs: * Education Reimbursement program for full-time employees * Monthly Cell Phone and Remote Work Allowance (dependent on role eligibility) * One time office setup allowance (can be used to purchase a scanner/printer, extra monitor, office furniture, etc.) * Working while visiting program – up to 4 weeks per year! * Flexible Summer Hours Program from May – September * Employee referral incentive – we know great people know other great people, and we think that warrants recognition! * Full-time employees also become beneficiaries of the Alimentiv Trust after one year of employment, and permanent members after 5 years of employment * Optional formal mentorship program (Alimentorship); country/region annual social events in person; leadership development programs for people leaders in accordance with your seniority; social committee and several other optional initiatives designed to support you in feeling like part of the Alimentiv team! Additional benefits may be available depending on the country of employment and are subject to local policies and eligibility. ### Our Services * End-to-end GI clinical trial services, from protocol design through submission support * Central medical imaging management and endoscopic reading * Precision medicine and biomarker solutions * Real-world evidence and clinical consulting * Histopathology and lab services through AcelaBio ### How to Apply To apply for this position, please submit your resume through the Alimentiv Careers Portal or via LinkedIn’s Easy Apply. Resumes must be submitted in English. ### Equal Opportunity and Accessibility Alimentiv is committed to building a diverse, inclusive and respectful workplace. We are an equal opportunity employer and consider all qualified applicants for employment without regard to race, colour, ethnicity, national origin, religion or belief, sex, gender identity or expression, sexual orientation, age, marital or family status, disability, or any other characteristic protected by applicable law. Accommodations are available upon request for persons with disabilities throughout the recruitment and selection process. Requests can be directed to [recruitment@alimentiv.com](mailto:recruitment@alimentiv.com). ### Compensation + Bonus ### Additional Information Stay Alert to Recruitment Scams Alimentiv is aware of a continued increase in phishing scams, which use various methods of attack via email, text, voice and social media, including individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from company email addresses containing “@alimentiv.com”. If you are contacted about an open job at Alimentiv, please verify the domain of the sender’s email address and confirm that you are being asked to apply on this website. If something doesn’t feel right, we encourage you to verify before responding. If you believe you have been the victim of a phishing scam, please contact your local government cyber authority to report it. Show more [Apply now >](https://jobicy.com/jobs/159260-gcp-computer-system-validation-specialist-12-month-limited-term.md) * ![Upload CV](data:image/svg+xml;base64,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) ### Upload your resume now To unlock remote work opportunities and be discovered by global employers. This job listing has been manually reviewed by the Jobicy Trust & Safety Team for compliance with our posting guidelines, including verification of the company's legitimacy, accuracy of job details, clarity of remote work policy, and absence of misleading or fraudulent content. ## Role DNA A quick view of the complexity, pace, ownership and collaboration implied by the job description. ### Job Complexity 4/5EasyHard ### Pace & Pressure 4/5RelaxedFast-paced ### Autonomy Level 4/5GuidedFull ownership ### Communication Load 5/5IndependentCollaborative AI insightThe role combines technical system-validation work with strict GxP and regulatory documentation requirements. Success depends on independently managing detailed evidence while aligning multiple technical and quality stakeholders. ## Salary analysis Estimated compensation compared with the broader CA market for similar roles. Estimated job median (per year)Market rateC$92,000CA market range (per year)C$75k–C$120k0C$132k AI insightThe employer lists a base salary range of CAD 69,000–115,000 per year, with a midpoint of CAD 92,000 annually. This is broadly plausible for a Canadian CSV specialist with 3–5 years of regulated-industry experience; the estimated Canadian market range is CAD 75,000–120,000 per year. ## Core skills Skills and capabilities most closely associated with this opportunity. [Computer System Validation](https://jobicy.com/jobs?search_keywords=Computer%20System%20Validation.md)[GxP compliance](https://jobicy.com/jobs?search_keywords=GxP%20compliance.md)[GCP validation](https://jobicy.com/jobs?search_keywords=GCP%20validation.md)[21 CFR Part 11](https://jobicy.com/jobs?search_keywords=21%20CFR%20Part%2011.md)[Validation planning](https://jobicy.com/jobs?search_keywords=Validation%20planning.md)[Test script development](https://jobicy.com/jobs?search_keywords=Test%20script%20development.md)[Traceability matrices](https://jobicy.com/jobs?search_keywords=Traceability%20matrices.md)[Validation documentation](https://jobicy.com/jobs?search_keywords=Validation%20documentation.md)[Defect management](https://jobicy.com/jobs?search_keywords=Defect%20management.md)[Deviation management](https://jobicy.com/jobs?search_keywords=Deviation%20management.md)[Change control](https://jobicy.com/jobs?search_keywords=Change%20control.md)[SDLC](https://jobicy.com/jobs?search_keywords=SDLC.md)[Audit readiness](https://jobicy.com/jobs?search_keywords=Audit%20readiness.md)[Quality assurance](https://jobicy.com/jobs?search_keywords=Quality%20assurance.md)[Stakeholder collaboration](https://jobicy.com/jobs?search_keywords=Stakeholder%20collaboration.md) Sample interview questionsHow do you approach validation planning for a new GCP-regulated computerized system?I begin by clarifying intended use, system risk, applicable regulations, and quality requirements with business, IT, and QA stakeholders. I then develop a risk-based validation plan that defines deliverables, responsibilities, testing scope, acceptance criteria, traceability, deviation handling, and approval requirements. What is your experience with 21 CFR Part 11 compliance? I assess controls around user access, audit trails, electronic signatures, record retention, and system security. I document how requirements are met through specifications, configuration evidence, test scripts, and traceability, while escalating any gaps through the quality process. How would you manage a defect discovered during validation testing? I would record the defect with clear reproducible evidence, assess its impact on patient safety, data integrity, and intended use, and coordinate triage with the appropriate stakeholders. I would ensure the resolution is tested, documented, linked to requirements, and formally closed according to the deviation or incident process. How do you maintain traceability across the validation lifecycle? I use a traceability matrix to connect user requirements to functional or configuration specifications, risk controls, test cases, results, and final release evidence. I review it throughout the project to ensure every applicable requirement is tested and that changes are reflected in the validation package. Describe how you communicate complex compliance issues to nontechnical stakeholders. I translate regulatory and technical concerns into clear business impact, risk level, and recommended actions. I use concise written summaries, practical examples, and decision-focused discussions so stakeholders understand what is required for compliance without unnecessary jargon. Next step ## Apply now. Follow the employer’s application method and review Jobicy’s safety guidance before sharing personal information. 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