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
- Strong 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.

📌 Computer System Validator at API (Edmonton)
🏢 BioTalent Canada
📍 Edmonton