Description
Our client, a medical device company based in the North of Germany, is looking for a Qualification / Validation Engineer to support ongoing work on site.Start: Middle of February 2015
Duration: End of December 2015
Location: Hamburg area
Experience in the following areas:
• Test Method Validation
• Laboratory and calibration knowhow
• Project management experience
Role and Requirements
Validation support for:
• Qualification protocols writing and execution (Installation, Operational and Performance Qualification)
• Validation Master Plan
• Cleaning Validation Process Validation
• Media Fill Protocols
• Calibration services
• Technology Transfer
• Process Analytical Technology (PAT) Support
• Clean Room qualification
• Temperature mapping
Key knowledge in Project Management:
• Project Planning and Status update
• Project Issues Tracking and Management
• Regulatory Exposure Warning
• Resource Capacity Plan
• Project Effort Reporting
• Meeting and Project Information Reporting
Non-Technical profile requirements:
• Some flexibility in working hours is required
• Must be able to work on multiple simultaneous tasks with limited supervision
• Quick learner, motivated self-starter
• Excellent customer service, interpersonal, communication and team collaboration skills
• Able to follow change management for internal guidelines
• Organisational talent, reliability, flexibility, personal initiative
• Good knowledge of Microsoft Office
• Ability to perform under pressure
• Fluent German is a must, fluent English is preferred