Senior Quality Control (QC) Engineer

Position Description

CGI is seeking a Senior Quality Assurance & Validation Engineer to support the development and delivery of an AI-enabled platform within the life sciences industry. This role will lead software testing, validation, and User Acceptance Testing (UAT), with a particular focus on ensuring the quality and compliance of AI-generated code and AI-driven document processing capabilities.

This is an opportunity to work at the intersection of Artificial Intelligence, software quality engineering, and regulated life sciences. You will partner closely with AI engineers, product teams, and regulatory stakeholders to build quality and validation into the development lifecycle while ensuring solutions meet GxP, Computer Software Validation (CSV), and 21 CFR Part 11 requirements.

Location: This role can be based near any CGI office in the U.S. and will follow CGI's hybrid working model. Strong preference will be given to candidates located in Pennsylvania, New Jersey, or New York.

Your future duties and responsibilities

• Lead testing, validation, and UAT activities for an AI-enabled life sciences platform.
• Develop and execute automated testing strategies, including the use of AI-assisted testing and automated test-generation tools.
• Validate AI-generated code and assess AI-identified software defects and anomalies.
• Test AI-driven document processing capabilities, including document extraction, classification, metadata accuracy, version lineage, and audit trail integrity.
• Develop and maintain Computer Software Validation (CSV) documentation, test protocols, validation plans, and supporting evidence in accordance with GxP requirements.
• Ensure electronic records, document histories, audit trails, and traceability meet applicable 21 CFR Part 11 requirements.
• Build and maintain automated test suites using frameworks such as Selenium, Playwright, or similar technologies.
• Partner closely with AI engineers to establish validation criteria for AI extraction, classification, and orchestration capabilities before solutions progress to UAT.
• Review Python and/or JavaScript code and AI-generated code outputs to identify potential quality, reliability, and testing concerns.
• Collaborate with engineering, product, quality, and regulatory stakeholders to identify compliance risks early in the development lifecycle.
• Help evolve quality engineering and validation practices as AI-assisted development capabilities mature.
• Drive continuous improvement and automation across testing, validation, and quality assurance processes.

Required Qualifications To Be Successful In This Role

• 5+ years of experience in software quality assurance, quality engineering, software validation, or test automation.
• Hands-on experience developing and executing automated software testing.
• Experience with test automation frameworks such as Selenium, Playwright, or comparable tools.
• Experience with AI-assisted testing, automated test generation, or testing AI-enabled applications.
• Ability to read and understand Python and/or JavaScript to evaluate application behavior and AI-generated code.
• Experience working within the life sciences, pharmaceutical, biotechnology, medical device, or other regulated healthcare environments.
• Strong understanding of Computer Software Validation (CSV) and validation practices within GxP-regulated environments.
• Experience developing validation documentation, test protocols, test scripts, and supporting evidence.
• Strong analytical skills with the ability to identify quality, compliance, and software risks.
• Strong communication skills with the ability to work effectively across engineering, quality, business, and regulatory teams.

Desired Qualifications

• Experience with 21 CFR Part 11 requirements and electronic records/electronic signatures compliance.
• Experience testing AI/ML-enabled applications, including document extraction, classification, or intelligent document processing solutions.
• Familiarity with document management, document control, and version-control systems.
• Understanding of responsible AI principles, AI validation methodologies, model/output quality, and potential bias in AI-assisted testing.
• Experience working within Agile or AI-assisted software development environments.
• Familiarity with modern CI/CD and automated quality engineering practices.

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 $79,600- $167,200.

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.

Together, as owners, let’s turn meaningful insights into action.

Life at CGI is rooted in ownership, teamwork, respect and belonging. Here, you’ll reach your full potential because…

You are invited to be an owner from day 1 as we work together to bring our Dream to life. That’s why we call ourselves CGI Partners rather than employees. We benefit from our collective success and actively shape our company’s strategy and direction.

Your work creates value. You’ll develop innovative solutions and build relationships with teammates and clients while accessing global capabilities to scale your ideas, embrace new opportunities, and benefit from expansive industry and technology expertise.

You’ll shape your career by joining a company built to grow and last. You’ll be supported by leaders who care about your health and well-being and provide you with opportunities to deepen your skills and broaden your horizons.

Come join our team—one of the largest IT and business consulting services firms in the world.

Qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, pregnancy, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status or responsibilities, reproductive health decisions, political affiliation, genetic information, height, weight, or any other legally protected status or characteristics to the extent required by applicable federal, state, and/or local laws where we do business.

CGI provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job in the U.S., please email the CGI U.S. Employment Compliance mailbox at [email protected]. You will need to reference the Position ID of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a Position ID will not be returned.

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All CGI offers of employment in the U.S. are contingent upon the ability to successfully complete a background investigation. Background investigation components can vary dependent upon specific assignment and/or level of US government security clearance held. Dependent upon role and/or federal government security clearance requirements, and in accordance with applicable laws, some background investigations may include a credit check. CGI will consider for employment qualified applicants with arrests and conviction records in accordance with all local regulations and ordinances.

CGI will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with CGI’s legal duty to furnish information.