Remote CSA Expert — Computer System Validation Lead

argenx US; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

argenx US is seeking a knowledgeable CSA professional to manage validation projects across a wide enterprise scope, ensuring compliance with global regulations and quality standards. You will translate risk-based validation strategies into actionable project plans and lead teams to deliver robust validation packages that safeguard data integrity.

The role emphasizes collaboration with cross-functional teams, SDLC expertise, and hands-on leadership in a fast-moving biopharma environment.

Qualifications

• Bachelor's or Master Degree preferred in Life Sciences, Engineering, Computer Science, Information Systems or related fields.
• Experience in a validation role with responsibility for managing the validation of GxP computer systems in a biopharma 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 specialists or contractors is a plus.

Responsibilities

• Develop and execute risk-based validation plans for assigned computer system projects, ensuring alignment with the enterprise CSA methodology and regulatory expectations.
• Manage the creation and review of all validation lifecycle documentation for specific projects, including Validation Plans, Test Plans, and Traceability Matrices as per procedure.
• Lead and manage the day-to-day execution of validation testing, coordinating with project teams, business users, and Digital Quality to ensure protocols are followed correctly and on schedule.
• Ensure the validated state of systems is maintained by managing validation activities related to change controls and contributing to periodic reviews.
• Act as the primary validation point of contact for assigned projects, providing expert guidance and resolving execution-level challenges.

Skills

CSA knowledge

Validation testing

SDLC familiarity

Cross-functional collaboration

Education

Bachelor's or Master's in Life Sciences/Engineering/CS

GxP validation experience

Tools

IQ/OQ/PQ protocols

Traceability matrices

Job description

argenx US is seeking a knowledgeable CSA professional to manage validation projects across a wide enterprise scope, ensuring compliance with global regulations and quality standards. You will translate risk-based validation strategies into actionable project plans and lead teams to deliver robust validation packages that safeguard data integrity.

The role emphasizes collaboration with cross-functional teams, SDLC expertise, and hands-on leadership in a fast-moving biopharma environment.