Validation Engineer (m/w) - open end temporary contractLHH

The Adecco Group Switzerland

For one of our clients in Life Sciences based in Le Locle, we are looking for a Validation Engineer for an open-end temporary contract.

Your responsibilities:

• Generation and execution of qualification/validation protocols including the generation, routing and approval of summary documentation
• Work with project teams to develop DOEs and statistically sound tests for appropriate support of results.
• Facilitate the execution of Process FMEA and other applicable risk analysis as deemed appropriate.
• Complete test method validation, gauges R&R studies and other qualifications or studies to support product testing
• Scheduling coordination, material allocation and alignment of personnel in order to successfully complete validation assignments
• Develop statistically based sampling plans for in-process and final test sequencing
• Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements
• Support and address comments and suggestions associated with validation and engineering documentation
• Protocol, Deviation, and summary report generation and approval
• Change control, non-conformance and CAPA support
• Participate in FDA inspections, ISO certifications, surveillance audits and customer audits

Your profile:

• Bachelors Degree in Engineering (Medical Device, biomedical, mechanical or chemical) or Science (Biology, Chemistry)
• 2 to 5 years of experience in a Validation or Quality Assurance role for a medical device or pharmaceutical company
• Fluent in French and in English
• Demonstrates excellent organizational and communication skills
• Experience with qualifying medical device manufacturing equipment
• Excellent technical writing skills with a thorough understanding of good documentation practice
• Competent in tracking and updating schedules to provide upper management visibility of milestones and achievements
• Use of Agile, Oracle, Minitab is a plus
• Use of Microsoft office tools
• Strong knowledge of statistical technics