Senior Quality Control (QC) Engineer

Category: Software Development/ Engineering

Main location: United States, Pennsylvania, Plymouth Meeting

Position ID:J0826-1401

Employment Type: Full Time

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.

#LI-MP2

Skills:

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