Computer System Validation Engineer
Core
Ensuring computer systems and applications comply with regulatory requirements and industry standards through planning, executing, and documenting validation activities.
Role type
Computer System Validation Engineer
Builds
Validated computer systems and applications for regulated industries
Domain
Medical devices / Optics and optoelectronics / Regulatory Compliance
Deliverable
client delivery
Required skills
Validation planning and protocol development, Risk assessment and mitigation, IQ/OQ/PQ execution, Regulatory compliance knowledge (FDA 21 CFR Part 11, GxP, EU MDR, ISO 13485), Validation documentation creation, Cross-functional collaboration
Preferred skills
ERP system validation, QMS software validation, LIMS validation, MES validation
Technologies
ERP systems, QMS software, LIMS, MES
Responsibilities
Develop and maintain validation plans, protocols, and reports; Conduct risk assessments; Perform Installation, Operational, and Performance Qualification; Create and maintain validation documentation; Ensure compliance with regulations like FDA 21 CFR Part 11 and GxP; Collaborate with IT, Quality Assurance, and Operations teams; Participate in internal and external audits
Seniority
Mid-Senior, hands-on IC
