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Added 12 mins ago
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Senior Finance Analyst, Operations Finance & Analytics
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Billennium

Validation Analyst

Canada

Full-time

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Job details

Job type: Full-time
Posting language: English
Posted: Oct 30, 2026

Original job description

We are looking for a Validation Analyst to join our team and support validation activities within a regulated life sciences environment. This role is a great opportunity for someone who enjoys working at the intersection of technology, quality, and business processes, ensuring that systems and solutions meet applicable compliance and validation requirements.

Tasks & Responsibilities:

-Validation Strategy: Develop and implement a validation strategy for digital solutions, ensuring alignment with regulatory requirements, industry best practices, and Roche's internal standards.

-Validation Plans and Protocols: Create validation plans and protocols for digital solutions, including data pipelines and interfaces, automation applications, data-driven models, and statistical tools. Ensure that all validation activities are properly documented and executed according to established procedures.

-Risk Assessment: Conduct risk assessments to identify potential risks associated with the use of digital solutions in a GMP environment. Develop risk mitigation strategies and ensure that appropriate controls are in place.

-Testing and Qualification: Collaborate with cross-functional teams to perform testing and qualification activities for digital solutions, particularly with QA SMEs. This includes executing test cases, analyzing results, and documenting findings.

-Compliance and Documentation: Ensure that all validation activities are compliant with relevant regulatory requirements, such as GMP and data integrity guidelines. Maintain accurate and up-to-date validation documentation, including validation plans, protocols, reports, and change control documentation.

-Continuous Improvement: Drive continuous improvement initiatives related to validation processes, tools, and methodologies. Stay updated with the latest industry trends and regulatory requirements in the field of validation.

-Communication and stakeholder management: Act as an interface between business and IT functionals and as a contact point for business leads in order to launch initiatives, leading and driving the scoping phase.

Requirements:

-Understanding of software development lifecycle models and experience with business/end-user applications.

-Strongge in validation principles and practices in a GMP environment. Experience in validating digital solutions, including Release Management processes and controls, as well as validation of statistical and data-driven models. Familiar with test automation process and development.

-Experience in managing infrastructure through multiple product releases, and have passion for reliability and security. Work with management to set priorities, track operational metrics.

-Demonstrate knowledge of current GxP requirements and documentation standards with the ability to write validation docs.

-Knowledge of pharma and/or cell & gene therapy supply chain processes is a plus.

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More about this job

Responsibilities

Develop and implement validation strategies, plans, and protocols for digital solutions in a regulated GMP environment, including data pipelines, interfaces, automation applications, and statistical tools. Conduct risk assessments, coordinate testing and qualification with cross-functional teams, maintain compliant documentation, and drive process improvements while serving as a liaison between business and IT stakeholders.

Requirements

Candidates should understand software development lifecycle models and have experience validating business applications and digital solutions in a GMP environment, including release management and statistical or data-driven models. They should be familiar with test automation, infrastructure releases, reliability and security, GxP requirements, and validation documentation; knowledge of pharmaceutical or cell and gene therapy supply chains is an advantage.

Skills

GMP Validation
Validation Strategy
Validation Planning
Risk Assessment
Test Execution
Release Management
Test Automation
Data Integrity
Regulatory Compliance
Statistical Model Validation
Data-Driven Model Validation
Change Control
Stakeholder Management
Infrastructure Reliability
Security

Visa sponsorship

Not detected in the job text

Keywords

GMP
GxP
Digital Solutions
Validation Strategy
Validation Plans
Validation Protocols
Risk Assessment
Risk Mitigation
Data Pipelines
Interfaces
Automation Applications
Statistical Tools
Data-Driven Models
Release Management
Test Automation
Data Integrity
Change Control
Qualification Testing
Regulatory Compliance
Validation Documentation
Infrastructure Management
Reliability
Security
Pharmaceutical Supply Chain
Cell and Gene Therapy

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