Senior Quality Control (QC) Engineer - AI-Driven Testing & Validation

Category: Testing/Quality Assurance

Main location: United States, New Jersey, New Brunswick

Position ID:J0726-1343

Employment Type: Full Time

Position Description:

CGI is seeking a forward-thinking Senior QC Engineer to lead software quality assurance, validation, and User Acceptance Testing (UAT) for our next-generation life sciences document version control platform. This role will leverage cutting-edge AI testing capabilities and support an AI-assisted software development lifecycle while ensuring compliance with GxP and other regulatory standards.

This position can be based near any CGI US office in a hybrid work model.

Focus: AI-powered software quality assurance and validation
Domain: Life sciences document management and version control
Environment: AI-assisted software development
Objective: Deliver high-quality, compliant software that meets GxP and regulatory requirements

Your future duties and responsibilities:

AI-Driven Testing & User Acceptance Testing

* Leverage AI-powered testing tools to improve software quality and testing efficiency.
* Design, generate, and maintain automated test cases using AI-assisted testing technologies.
* Validate AI-generated code and ensure it meets functional, performance, and compliance requirements.
* Plan, coordinate, and execute User Acceptance Testing (UAT) with business stakeholders.
* Analyze AI-identified defects, anomalies, and risk areas, ensuring timely resolution.

Validation & Regulatory Compliance

* Ensure software development and testing activities comply with GxP regulations and Computer Software Validation (CSV) requirements.
* Develop and maintain validation documentation, including validation plans, protocols, test scripts, and summary reports.
* Support audit readiness by maintaining complete traceability of electronic records and testing evidence.
* Ensure solutions comply with FDA 21 CFR Part 11 and other applicable regulatory standards.

Collaboration & Continuous Improvement

* Partner closely with AI-assisted software developers, product owners, and business stakeholders to define quality requirements.
* Collaborate with Quality Assurance and Regulatory teams to ensure validation activities align with compliance expectations.
* Drive continuous improvement of quality engineering processes, automation frameworks, and AI-enabled testing practices.

Required qualifications to be successful in this role:

* 5+ years of experience in software Quality Assurance, Quality Control, or Software Validation.
* Experience using AI-enabled software testing or test automation platforms.
* Hands-on experience with test automation frameworks such as Selenium or Playwright.
* Ability to read, understand, and troubleshoot code written in Python or JavaScript.

Domain Expertise

* Experience in the life sciences, pharmaceutical, biotechnology, or healthcare industries.
* Strong understanding of Computer Software Validation (CSV) methodologies and GxP regulations.
* Experience testing document management, document control, or regulated content management systems is preferred.
* Familiarity with FDA 21 CFR Part 11 and electronic records/electronic signatures compliance.

Professional Skills

* Strong analytical and problem-solving abilities with exceptional attention to detail.
* Understanding of AI governance, validation, and the importance of mitigating bias in AI-assisted solutions.
* Excellent communication and collaboration skills with cross-functional technical and regulatory teams.
* Ability to thrive in a fast-paced Agile development environment supporting rapid AI-enabled innovation.

Bachelor's degree in computer science, Engineering, or a related field, or equivalent professional experience.

Other Information:
CGI is required by law in some jurisdictions to include a reasonable estimate of the compensation range for this role. The determination of this range includes various factors not limited to skill set, level, experience, relevant training, and licensure and certifications. To support the ability to reward for merit based performance, CGI typically does not hire individuals at or near the top of the range for their role. Compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range for this role in the U.S. is $77,800.00 $103,800.00.

CGI's benefits are offered to eligible professionals on their first day of employment to include:
. Competitive compensation
. Comprehensive insurance options
. Matching contributions through the 401(k) plan and the share purchase plan
. Paid time off for vacation, holidays, and sick time
. Paid parental leave
. Learning opportunities and tuition assistance
. Wellness and Well being programs

#LI-MP2

Skills:

• LangChain
• Life Sciences
• Python (Anaconda) AI/ML
• AI Business Strat&Applications
• Selenium