Computer System Validation Specialist – 12 Month Limited-Term

This is a fully remote position, open to applicants in Canada.

📋 Description

• Conduct validation activities for computerized systems and software, ensuring compliance with GxP, 21 CFR Part 11, and relevant regulatory standards.

• Create and maintain validation plans, test scripts, traceability matrices, summary reports, and release documentation.

• Collaborate with IT, Quality Assurance, business stakeholders, and external vendors to establish validation strategies and execute projects.

• Organize and supervise validation testing activities.

• Manage defects, deviations, and incidents, including triaging, tracking resolutions, and documenting closures.

• Oversee the review, approval, execution, and post-execution management of validation and qualification documents.

• Educate and assist project teams regarding validation procedures, tools, documentation standards, and industry best practices.

• Direct change management processes for validated systems.

• Keep abreast of changing regulatory requirements and industry standards.

⛳️ Requirements

• A Bachelor's degree in Computer Science, Information Technology, Engineering, Software Development, or a related field, complemented by 3-5 years of relevant experience, or an equivalent combination of education and experience.

• Proven experience in validating GCP-regulated computerized systems and software.

• Ideally, experience within the pharmaceutical, biotechnology, medical device, or other highly regulated sectors.

• Strong knowledge of quality system principles, including validation, documentation, change control, training, and audit preparedness.

• Capability to work collaboratively in cross-functional and matrixed environments.

• Skill in building relationships with internal stakeholders, business partners, and external vendors.

• Exceptional written and verbal communication abilities.

• Proficient in documenting, presenting, and articulating technical and compliance-related information clearly.

• Experience in Software Development Lifecycle (SDLC) processes.

• Familiarity with automated testing tools and enterprise validation technologies is considered advantageous.

• Resume must be submitted in English.

🏝️ Benefits

• Bonus.

• Education Reimbursement program for full-time employees.

• Monthly Cell Phone and Remote Work Allowance (dependent on role eligibility).

• One-time office setup allowance.

• Working while visiting program – up to 4 weeks per year.

• Flexible Summer Hours Program from May – September.

• Employee referral incentive.

• Full-time employees become beneficiaries of the Alimentiv Trust after one year of employment and permanent members after 5 years.

• Optional formal mentorship program (Alimentorship).

• Country/region annual social events in person.

• Leadership development programs for people leaders in accordance with seniority.

• Social committee and other optional initiatives.

• Additional benefits may be available depending on the country of employment and local policies and eligibility.

• Flexible remote work arrangement.