Senior Validation Engineer

The opportunity:

In this job function, your primary role will be to manage the overall validation activities in the company and to

In this position you will be asked to:

• Provide guidance and support to all departments/staff as needed regarding related issues, ensuring compliance, as applicable, with ISO13485 FDA and other Quality Standards, Validation Regulations and Guidance Documents.

• Maintain on-going understanding and knowledge of the latest regulatory requirements for validation in compliance with EU/U.S. regulations and guidance documents.

• Monitor the progress of validation projects on a daily/weekly basis ensuring that there is continuous drive/focus on meeting schedules.

• Participate in/Lead the review of validation practices in the company; monitor trends, and initiate improvement opportunities.

• Write Validation Protocols and Reports, master plan and etc. compelling to all relevant Quality Standards and Regulatory requirements.

• Execution and completion of process, equipment and product validations and revalidations in accordance with Validation Master Plans, schedules, and Company policy.

• Co-ordinate activities in all areas of validation

• Participate in cross functional teams to establish validation strategies and objectives to support the business

• As needed, providing related training and support.

A successful candidate will have the following qualifications:

• 5-7 years of experience in validation in a medical device company

• B.Sc. Engineer in Biomedical/Biotechnology – an advantage

• Experience in data analysis – an advantage

• Strong background in qualification documentation review

• Strong technical and engineering knowledge

• Excellent written and verbal communication skills in both Hebrew and English

• A team player with strong communication and collaboration skills