Validation Engineer (Germany)
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Location: |
EU
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Qualifications: |
Degree |
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Experience: |
2-3 Years |
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Job Type: |
Permanent
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Salary: |
Negotiable |
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Consultant: |
James Cassidy 01-6854545 |
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Validation Engineer (Germany)
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Our client a multinational medical device company currently seeks a validation engineer to develop specifications and inspection criteria, create and update the Quality Assurance documentation and instructions in line with the Medical Devices Directive especially for medical devices containing an ancillary medicinal substance. Successful candidate must be fluent in German and be able to relocate to Germany
Role/Responsibilities
• Create validation plans/protocols for manufacturing processes in an GMP environment
• Apply the GHTF validation guideline
• Apply technical solutions to problem solving especially for medical devices containing an ancillary medicinal substance within GMP, EMEA and ICH-guidelines
• Apply technical solutions to quality improvement projects
• Use technical writing skills to clearly describe technical information
• Analyze customer complaints, identify trends and execute corrective actions
• Understand standards and their application to medical devices
• Planning, protocol generation, testing and report generation for medical devices
• Generation and maintenance of Technical Files for medical devices
• Review and update technical files in line with EU medical devices regulatory requirements
• Ensuring that records are filed in accordance with site procedures.
• Supporting R&D projects
Skills / Experience
• Engineering/Science qualification with about 5 years of work experience within R&D/QA/RA in a medical device or pharmaceutical environment.
• 2/3 years experience in R&D, QA/RA, Process Validations – essential
• 2/3 years experience in Risk, Clinical and Biocompatibility – an advantage
• Excellent technical writing experience within a medical device or pharmaceutical environment - essential
• Attention to detail and accuracy – essential
• Fluent English, both written and oral - essential
• Ability to work well under deadlines and pressure
• Problem solving skills for developing creative solutions and meeting objectives are required.
• Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel);
• Excellent analytical ability
• The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.
For immediate consideration please apply online now or contact James Cassidy on +353 1 685 45 45
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