Extracted from the posting
TL;DR
12-month limited-term role validating GCP-regulated computerized systems against GxP and 21 CFR Part 11. Responsibilities include writing validation plans, test scripts, traceability matrices and summary reports, and managing defects and deviations. Works with IT, Quality Assurance, business stakeholders and external vendors.
The full posting
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
Our Services
How to Apply
Equal Opportunity and Accessibility
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.
Compensation: CAD 69,000 – 115,000 per year salary
Company stack
This posting doesn’t list technologies. These are the ones Alimentiv uses across its other roles.