Validation Engineer (w/m/d)
Core
Analyze customer specifications for feasibility and cost, manage QA activities, and ensure CE compliance for industrial plants in regulated sectors.
Role type
Validation Engineer (QA/Compliance)
Builds
Industrial plants and components for pharmaceutical, medical device, and automotive clients
Domain
Industrial manufacturing / Regulatory compliance (Pharma, MedTech, Automotive)
Deliverable
client delivery
Required skills
Risk assessment, Qualification/Validation planning, Documentation management, Regulatory knowledge (Pressure Equipment Directive, Machinery Directive, ASME), Negotiation
Preferred skills
cGMP (EU, FDA) implementation, Experience in Pharma/MedTech/Automotive, Technical acceptance regulations
Technologies
ASME, Pressure Equipment Directive, Machinery Directive
Responsibilities
Analyze customer specifications for feasibility and cost estimation, Coordinate and release qualification documentation, Conduct risk assessments, Ensure CE compliance and coordinate acceptance with authorized bodies, Negotiate results with customers
Seniority
Mid-level IC
