Application V&V Engineer (m/f/d)
Core
Lead verification and validation (V&V) of applications interfacing with multiple subsystems in life sciences and diagnostics, ensuring compliance with regulatory standards and quality management systems.
Role type
Senior Application V&V Engineer
Builds
Integrated systems for cell therapy, vaccines, and medicines
Domain
Life sciences / Biotechnology / Medical devices
Required skills
Systems Engineering, V&V strategy definition, Test execution, Risk management, Regulatory compliance (ISO 13485, cGMP), Cross-functional collaboration, Defect investigation, Technical mentorship, Process optimization
Preferred skills
Mechanical/Electrical/Biomedical subsystem knowledge
Technologies
Java, Python, C#
Responsibilities
Define V&V scope, strategies, plans, and procedures; Execute test protocols and traceability matrices; Collaborate with System Engineering, Biology, and Software teams; Serve as SME for V&V methodologies; Investigate defects and root causes; Mentor junior engineers; Drive continuous improvement of V&V processes
Seniority
Senior, hands-on IC