Job Description

Computer System Validation (CSV) Specialist

Infiligence - Calgary, Alberta

About Infiligence

Infiligence is a North American-based IT services firm specializing in the life sciences sector. We partner with digital health companies, biotech firms, pharmaceutical manufacturers, and medical device innovators to deliver compliant, modern technology solutions-from DevOps and cloud modernization to CSV/QE and interoperability services.

The Role

We're expanding our Canadian validation practice in Calgary to support our growing portfolio of life science clients across North America. This role offers direct engagement with innovative digital health companies, emerging biotech firms, and established pharmaceutical organizations navigating FDA, Health Canada, and EMA regulatory requirements.

Responsibilities

Validation Program Delivery

• Lead end-to-end computer system validation activities for regulated life science applications
• Author and execute validation protocols and reports (IQ/OQ/PQ, FAT/SAT)
• Develop Validation Plans, User Requirements Specifications (URS), Functional Specifications, and Traceability Matrices
• Conduct risk assessments using GAMP 5 risk-based approaches

Regulatory Compliance Leadership

• Ensure systems comply with FDA 21 CFR Part 11, Health Canada Guidance, GxP, EU Annex 11, and GAMP 5
• Perform data integrity assessments (ALCOA+ principles)
• Support Health Canada and FDA inspection readiness
• Validate cloud-based SaaS platforms and hybrid infrastructure

Quality & Process Excellence

• Participate in change control and deviation management processes
• Support CAPA investigations related to system validation
• Contribute to continuous improvement of validation methodologies
• Review vendor validation packages and audit third-party suppliers

Client & Stakeholder Engagement

• Interface directly with client Quality, IT, and Regulatory Affairs teams
• Present validation strategies and status updates to project stakeholders
• Support business development with validation assessments and proposals

Required Qualifications

Experience & Education

• Bachelor's degree in Life Sciences, Engineering, Computer Science, or related discipline
• 5+ years of progressive CSV experience in pharmaceutical, biotech, medical device, or digital health environments
• Proven track record delivering validation projects on time and within budget

Technical Expertise

• Comprehensive understanding of GAMP 5 (categories, risk-based validation, Agile validation)
• Deep knowledge of FDA 21 CFR Part 11, Health Canada regulations, GxP, and EU Annex 11
• Hands-on experience validating enterprise systems: LIMS, QMS, MES, ERP (SAP, Oracle), EDC, CTMS, LMS, EHR/EMR, Veeva Vault
• Experience with cloud validation (AWS, Azure, GCP) and SaaS applications
• Understanding of data integrity requirements and electronic records/signatures

Professional Skills

• Exceptional technical writing and documentation abilities
• Strong analytical thinking and attention to detail
• Excellent stakeholder management and communication skills
• Self-directed with ability to manage competing priorities
• Collaborative team player comfortable in fast-paced environments

Preferred Qualifications

• Experience with automated validation and continuous validation approaches
• Knowledge of DevSecOps and Infrastructure as Code (IaC) in regulated environments
• Familiarity with medical device standards (ISO 13485, IEC 62304)
• Prior experience with digital health applications and mobile medical apps
• Professional certifications: ISPE, RAPS (RAC), ASQ (CSQE, CQE), PMP
• Bilingual (English/French) is an asset

Location Details

• Office : Calgary, Alberta
• Work Model : Remote
• Travel : Occasional travel to client sites in Western Canada and US (10-15%)

Why Calgary?

Join Alberta's growing life science and digital health ecosystem. Calgary offers quality of life, proximity to the Rocky Mountains, no provincial sales tax, and increasing life science investment-while providing access to North American clients.

Application Process

Please submit your resume with the outlines below:

1. Your most complex validation project and regulatory framework involved
2. Systems and platforms you've validated
3. Your experience with risk-based validation approaches

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