Digital Technology Computer System Assurance Expert

argenx; Oregon; Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Retirement savings plans

Health benefits

Other benefits

Job summary

argenx is seeking a seasoned Computer System Assurance (CSA) professional to lead risk-based validation projects for computerized systems, ensuring compliance with global regulations and internal quality standards.

You will create and review Validation Plans, IQ/OQ/PQ protocols, and Traceability Matrices, manage testing, change controls, and cross-functional collaboration to deliver compliant, data-integrity focused solutions.

Qualifications

• Bachelor’s or Master degree in Life Sciences, Engineering, CS or related field.
• 5+ years in a validation role with GxP systems in biotech/medical devices.
• Experience authoring and executing validation deliverables for complex systems.

Responsibilities

• Develop and execute risk-based validation plans for computer system projects.
• Create and review Validation Plans, IQ/OQ/PQ protocols, and Traceability Matrices.
• Lead day-to-day validation testing and coordinate with cross-functional teams.
• Ensure validated state of systems through change controls and periodic reviews.
• Serve as primary validation contact and provide guidance on execution challenges.
• Co-create with teams to ensure timely, high-quality validation deliverables.

Skills

Validation planning

GxP validation

Risk-based validation

Project management

Education

Bachelor’s or Master degree

Tools

IQ/OQ/PQ protocols

Traceability matrices

Validation lifecycle docs

Job description

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.

This role is responsible for managing the execution of Computer System Assurance(CSA) projects for computerized systems, ensuring that projects are delivered incompliance with global regulations and internal quality standards. This positiontranslates the enterprise risk-based validation/qualification strategy into actionableproject plans, leading teams to create robust validation/qualification packages thatguarantee data integrity and support the successful implementation of technologysolutions that enable our business.

ROLES AND RESPONSIBILITIES

• Develop and execute risk-based validation plans for assigned computer systemprojects, ensuring alignment with the enterprise CSA methodology and regulatoryexpectations.
• Manage the creation and review of all validation lifecycle documentation for specificprojects, including Validation Plans, Test Plans, and Traceability Matrices as perprocedure.
• Lead and manage the day-to-day execution of validation testing, coordinating withproject teams, business users, and Digital Quality to ensure protocols are followedcorrectly and on schedule.
• Ensure the validated state of systems is maintained by managing validation activitiesrelated to change controls and contributing to periodic reviews.
• Act as the primary validation point of contact for assigned projects, providing expertguidance and resolving execution-level challenges.
• Co-create with project teams to ensure validation deliverables are completed on timeand with the highest level of quality and excellence.
• Support the continuous improvement of the risk based CSA process by providingfeedback from project execution to the validation capability lead.
• Empower project teams by providing clear direction and support on allvalidation/qualification-related tasks and activities.
• Skilled in developing project-level validation plans and executing the full range ofvalidation documentation and testing (CT/FT/UAT)
• Ability to act as a connector, translating validation strategy into clear, executabletasks for project teams and stakeholders.
• Knowledge of the system development lifecycle (SDLC) and project managementprinciples.
• Ability to work collaboratively and effectively together within cross-functional teamsand networks.
• Demonstrated communication skills, within a multi-cultural and multi-lingual globalenvironment.
• Is agile and demonstrates adaptability, comfort with ambiguity, trust-building, andresilience.
• Derives energy from acting as a hands-on leader in a dynamic, complex, and fastmovingenvironment.
• Demonstrable experience with project management, proactive planning, prioritysetting, and securing alignment.
• Drives toward outcomes.
• Ambitious, inquisitive naturally, a quick study, with demonstrated eagerness tocontinuously learn, self-improve and develop. This includes being comfortable givingand receiving feedback in a diverse environment.
• Passionate and prepared to lead and contribute to our culture, which is driven by ourcorporate values of co-creation, innovation, empowerment, excellence, and humility.

EDUCATION, EXPERIENCE AND QUALIFICATIONS

• Bachelor’s or Master Degree preferred in Life Sciences, Engineering, ComputerScience, Information Systems or related fields.
• Experience in a validation role with responsibility for managing the validation of GxPcomputer systems in a biopharmaceutical or medical device company. "5+ Years"
• Experience authoring and executing a full range of validation deliverables (e.g.,Validation Plans, IQ/OQ/PQ protocols, Traceability Matrices,…) for complex systems. "5+ Years"
• Experience leading project teams or managing the work of other validation specialistsor contractors is a plus.

#LI-remote

The annual base salary hiring range for this position is $0.00 - $0.00 USD. This range reflects our good faith estimate at the time of posting. Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity. This means actual pay may differ from the posted range when justified by these factors. Because market conditions evolve, pay ranges are reviewed regularly and may be adjusted to remain aligned with external benchmarks.

This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies.

• Retirement savings plans
• Health benefits
• Other benefits subject to the terms of the applicable plans and program guidelines

At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.