Gandiv Insights LLC · 3 hours ago
Validation Engineer - medical devices
Jersey City, NJ
Contract
Onsite
Mid, Senior Level
2+ years expGandiv Insights LLC is seeking a Validation Engineer responsible for planning, executing, and documenting validation activities for medical device manufacturing processes. The role ensures compliance with FDA and ISO requirements while collaborating with various teams to support validation and quality assurance activities.
Information Technology & Services
Responsibilities
Execute IQ/OQ/PQ for equipment, processes, and utilities
Perform process validation, equipment qualification, and test method validation
Prepare and maintain validation protocols, reports, risk assessments, and traceability documentation
Support change control, deviations, CAPA, and revalidation activities
Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and internal quality standards
Collaborate with QA, Engineering, Manufacturing, and Regulatory teams
Support internal and external audits and inspections
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or related field
2–5+ years of validation experience in medical devices
Strong knowledge of IQ/OQ/PQ and process validation principles
Working knowledge of FDA QSR, ISO 13485, and risk management (ISO 14971)
Strong documentation and communication skills
Company
Gandiv Insights LLC
Gandiv Insights is a leading professional services and staffing firm specializing in top-tier personnel and technical solutions across engineering, IT, non-IT, and healthcare sectors.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase