Validation Engineer
Core
Plan, execute, and document validation activities (VMP, IQ, OQ, PQ) to support compliant operations across the product and process lifecycle for medical device manufacturing.
Role type
Mid-level Validation Engineer
Builds
Validated equipment, processes, and systems for medical device production
Domain
Medical device manufacturing / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Equipment qualification, process validation, system validation, VMP development, protocol writing, report generation, change control management, deviation handling, CAPA support, audit preparation, risk mitigation, cross-functional collaboration
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead and execute equipment, process, and system qualification and validation activities; Develop, review, and approve validation master plans, protocols, reports, and supporting documentation; Partner with Manufacturing, Engineering, Quality, Regulatory, and Supply Chain to support new product introductions, capacity expansions, equipment transfers, and site expansion activities; Ensure validation practices meet customer requirements, internal standards, and regulatory expectations including FDA and ISO requirements; Maintain validation lifecycle compliance through change control, revalidation, periodic review, and support for deviations, CAPAs, and nonconformances; Participate in internal audits, customer audits, and regulatory inspections; Provide technical guidance to site teams and contribute to continuous improvement through standardization, templates, best practices, and risk mitigation
Seniority
Mid-level, hands-on IC
