Engineer, Validation (temporary 12 months)
Core
Manage the operational strategy of the validations area to ensure equipment, processes, and systems in the plant remain properly qualified and validated in accordance with regulatory standards.
Role type
Senior Validation Engineer / Quality Operations Manager
Builds
Qualified and validated equipment, processes, and systems for medical devices and pharmaceuticals
Domain
Regulated medical industries (pharmaceuticals, medical devices)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Resource management, Negotiation, Coordination, Competency assessment, Training facilitation, Process improvement, Data Integrity compliance, Regulatory compliance
Preferred skills
Excellence focus, Critical thinking, Project management, Adaptability
Technologies
GxP practices, EHS policies, Data Integrity frameworks
Responsibilities
Identify best practices in resource management, Negotiate priorities with customer areas and external representatives, Coordinate plant needs regarding equipment and process validation, Identify improvement opportunities and implement process changes, Ensure compliance with corporate and legal EHS requirements and regulatory standards, Ensure Data Integrity compliance with regulatory standards
Seniority
Senior, hands-on IC with management responsibilities