GxP Computer System Validation Lead

Argenx; United States; Remoto; USD 120.000 - 190.000; Tempo pieno

Vantaggi offerti da questo lavoro

Retirement benefits

Health insurance

Comprehensive benefits

Descrizione del lavoro

argenx is seeking a Senior Validation professional in the United States to develop and execute risk-based validation plans for computer systems, ensuring CSA-aligned regulatory readiness. You will lead the creation of validation documents and oversee testing across cross-functional teams.

The role emphasizes maintaining the validated state through change controls, mentoring project teams, and driving quality and agility in a fast-moving biotech environment.

Competenze

• Bachelor’s or Master degree 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 biopharmaceutical or medical device company.
• Experience authoring and executing a full range of validation deliverables (e.g., Validation Plans, IQ/OQ/PQ protocols, Traceability Matrices) for complex systems.

Mansioni

• Develop validation plans for computer systems in scope.
• Lead creation and review of validation documentation (Validation Plans, IQ/OQ/PQ, Traceability Matrices).
• Direct day-to-day validation testing with project teams and Digital Quality.
• Maintain validated state via change controls and periodic reviews.
• Act as primary validation point of contact for assigned projects.

Conoscenze

GxP validation

Project management

Cross-functional collaboration

Regulatory compliance

SDLC knowledge

Formazione

Bachelor’s or Master degree in Life Sciences or related fields

Experience in validation of GxP systems in biopharma/medical devices

Strumenti

Validation Plans

IQ/OQ/PQ protocols

Traceability Matrices

Change controls

Validation testing

Descrizione del lavoro

argenx is seeking a Senior Validation professional in the United States to develop and execute risk-based validation plans for computer systems, ensuring CSA-aligned regulatory readiness. You will lead the creation of validation documents and oversee testing across cross-functional teams.

The role emphasizes maintaining the validated state through change controls, mentoring project teams, and driving quality and agility in a fast-moving biotech environment.