Elevate drug production at API as a Computer System Validation Specialist focused on hardware and software. This on-site role ensures compliance with industry standards while supporting essential drug initiatives.
API is seeking a full-time Computer System Validation Specialist for a temporary contract. In this position, you will manage validation processes, including electronic QMS solutions and equipment, within the Canadian Critical Drug Initiative. This role emphasizes compliance and collaboration in a fast-paced pharmaceutical environment, where expertise in GMP operations is essential.
Key Responsibilities:
• Implement and qualify electronic QMS solutions
• Validate equipment and systems for GMP compliance




• Manage lifecycle of software systems and documentation
• Conduct risk assessments and propose system improvements
• Serve as the CSV technical expert for audits
Requirements:
• Bachelor's degree in engineering or IT-related field
• 3-5 years of applied CSV experience
• Solid knowledge of GMP, 21CFR11, GAMP5
• Expertise in electronic quality management systems
• Excellent communication skills with stakeholders
Contribute your CSV expertise to enhance critical drug production initiatives at API.
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📌 Computer System Validator at API (Edmonton)
🏢 BioTalent Canada
📍 Edmonton