GCP - Computer System Validation Specialist (12 month limited-term)

Technology and Innovation

Full-time, Permanent

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.