PTE Data/AI Validation Specialist

F. Hoffmann-La Roche Gruppe; Mississauga; On-site; CAD 80,000 - 110,000; Full time

Job summary

Join a forward-thinking company as a Data/AI Validation Specialist, where you will optimize data insights for pharmaceutical operations. In this pivotal role, you will validate AI models and data pipelines, ensuring compliance with regulatory standards. Collaborate with multidisciplinary teams to enhance data quality and drive innovation in healthcare solutions. This is an exciting opportunity to contribute to a healthier future and be part of a vibrant and collaborative culture that values every voice. If you're passionate about data and quality assurance, this role is perfect for you.

Qualifications

• 3+ years experience in IT & Software Validation, preferably in pharma.
• Strong understanding of database management and data analysis.

Responsibilities

• Author validation plans and review test plans to ensure compliance.
• Coordinate validation activities globally and collaborate with data teams.
• Validate end-to-end data products and support audit preparation.

Skills

Data Analysis

Software Validation (CSV, GAMP)

Problem Identification

Root Cause Analysis

Database Management

Quality Assurance Practices

Education

Bachelor's Degree in Computer Science

Master's Degree in Engineering or Statistics

Tools

SDLC Models and Standards

Job description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

At Roche, we thrive to deliver more benefits to our patients as part of our 10-year Pharma vision. An integral part of achieving this vision is to deliver new and innovative data analytics solutions to our scientists across Pharma Technical Operations (PT). PTE is the organization that catalyzes the global development and execution of PT’s Digital and Operational Excellence strategy to enable PT to realize our performance promises. We aim to activate data citizenship and digital mind, revolutionize our FAIR data ecosystem and systems landscape, re-design excellent processes, and generate transformative insights.

As a Data/AI Validation Specialist at Roche PT, you will play a pivotal role in optimizing access to the data insight that powers our pharmaceutical operations. This role is involved in validating AI models, data pipelines, and algorithms to meet business objectives, regulatory standards, and quality benchmarks. Working in multidisciplinary teams, you’ll execute and deploy deliverables based on the existing standards integral to our validation framework.

The Opportunity:

• You will author validation plans/reports, forecast validation activities, and review test plans/reports (and other deliverables) ensuring documentation is according to procedures.
• You will steer key performance indicators for performance and comprehensive product validation and participate in the traceability of data quality issues, effective problem identification and root cause analysis.
• You will coordinate and advise on all validation activities on a global level/organizational level and collaborate with data product teams for delivery of qualified global data products.
• You will validate comprehensive end-to-end data product and AI Model programs (including validation plans, protocols, and reports) and support audit/inspection preparation and execution as CSV subject matter expert.
• You will collaborate with quality assurance teams to ensure adherence to regulatory standards and industry best practices and ensure data validation practices comply with industry regulations such as regulatory guidelines, GDPR, HIPAA, or other standards.

Who you are:

• You have a bachelor's or Master's degree in Computer Science, Engineering, Statistics, or a related field. 3+ years experience in IT & Software Validation (CSV, GAMP), preferably in pharma environment.
• You have experience in software development lifecycle processes (SDLC), models, standards.
• You have experience in validation for projects, systems maintenance and related deliverables.
• You have experience in maintenance and support of applications under global inspection agencies, CFR 21 FDA Part 11, Annex 11. Broad knowledge in Manufacturing (Clinical or Commercial experience), or Experience with Supply Chain or Regulatory.
• You have a strong understanding of database management, data analysis, and quality assurance practices.

Relocation benefits are not available for this posting.

Who we are

A healthier future drives us to innovate. Together, more than 100,000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche's truly innovative culture.

Roche is an Equal Opportunity Employer.