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

Are you driven by the challenge of bringing life-changing therapies to patients, all while ensuring the highest standards of technological integrity? At Alimentiv, our global team is singularly focused on advancing treatments for gastrointestinal diseases, a mission that has guided our scientific rigor and operational excellence for over three decades. We're a “profit-with-purpose” company, reinvesting our success directly into research, technology, and our incredible people. Now, we're searching for a dedicated Computer System Validation (CSV) Specialist to join us for a 12-month limited-term, fully remote contract. If you're passionate about validating GCP-regulated systems, ensuring technology meets strict compliance in a dynamic environment, and truly making an impact on global health outcomes, we want to hear from you.

Overview

Alimentiv is a global Contract Research Organization (CRO) deeply committed to advancing therapies for patients grappling with gastrointestinal diseases. Our “WHY” has shaped our scientific approach and operational excellence for over 30 years, supporting a significant portion of IBD compounds in development. This specific role invites a talented Computer System Validation Specialist to play a pivotal part in ensuring our GCP-regulated systems meet rigorous quality and compliance standards, particularly on the Google Cloud Platform (GCP). You will work hand-in-hand with our IT, Quality, and business teams to deliver robust, compliant, and reliable technological solutions. This is a fully remote opportunity, open to candidates worldwide, offering you the flexibility to contribute from wherever you are.

Key Responsibilities

Lead Validation Planning and Execution: Drive the complete Computer System Validation lifecycle for GCP-regulated systems, from initial planning to final reporting.
Develop Comprehensive Documentation: Create and maintain essential CSV documentation, including Validation Plans, Requirements Specifications, Design Specifications, Traceability Matrices, Test Plans, Test Scripts, and Validation Reports.
Ensure GCP Compliance: Act as a subject matter expert, ensuring all validated systems adhere strictly to Good Clinical Practice (GCP) guidelines and other relevant regulatory requirements.
Collaborate Across Teams: Partner effectively with IT, Quality Assurance, and various business stakeholders to understand system needs and align on validation strategies.
Manage Testing Activities: Oversee and participate in system testing, ensuring test cases adequately cover requirements and risks.
Conduct Risk Assessments: Perform thorough risk assessments to identify and mitigate potential compliance and system integrity issues.
Support Audit Readiness: Contribute to internal and external audit readiness activities, providing expert support and documentation.
Drive Continuous Improvement: Proactively identify opportunities to enhance our CSV processes and methodologies.

Requirements

Proven CSV Experience: Substantial experience in Computer System Validation within a regulated environment, specifically with GCP-regulated systems.
GCP Expertise: In-depth knowledge of Good Clinical Practice (GCP) regulations and their application to computer systems.
Cloud Platform Familiarity: Hands-on experience with cloud computing environments, particularly Google Cloud Platform (GCP).
Life Sciences Background: Previous work experience in a CRO, pharmaceutical, or biotechnology setting is highly desirable.
Analytical and Problem-Solving Skills: Strong ability to analyze complex system processes, identify issues, and propose effective solutions.
Exceptional Communication: Excellent verbal and written communication skills for engaging with technical and non-technical stakeholders across different functions.
Detail-Oriented Approach: Meticulous attention to detail in documentation and execution of validation activities.
Self-Motivated and Adaptable: Ability to work independently in a remote setting and adapt to evolving project priorities.

What You'll Gain

Meaningful Impact: Directly contribute to research that changes lives and advances therapies for patients with gastrointestinal diseases.
Purpose-Driven Culture: Work with a company that channels its success back into scientific research, technology, and its people.
Professional Growth: Opportunities to expand your expertise in GCP and cloud-based CSV within a global, dynamic organization.
Flexible Work Environment: Enjoy the benefits of a fully remote, worldwide role that values work-life integration.
Collaborative Team: Join a supportive and expert team dedicated to quality and compliance.