Validation Engineer
Core
Ensuring medical device products comply with global, local, and internal regulations through planning, executing, and documenting validation studies for equipment, systems, and processes.
Role type
Associate II Validation Engineer (Quality & Regulatory Affairs)
Builds
Validated equipment, systems, and processes for global eye health products
Domain
Medical Devices / Regulatory Compliance / Quality Assurance
Required skills
validation study planning and execution, risk assessment, protocol design, data analysis, report preparation, change control review, audit support, GxP compliance, SOP adherence
Preferred skills
aseptic process management support, cross-functional collaboration, problem-solving, continuous improvement
Technologies
GxP regulations, Standard Operating Procedures (SOPs)
Responsibilities
Plan, execute, and document validation studies; conduct risk assessments and design protocols; review and approve change control documentation; provide audit support; adhere to GxP regulations and maintain accurate documentation.
Seniority
Associate II, hands-on IC
