Process Validation Engineer

We are looking for a Process Validation Engineer to join our team!

Location: Tzur Yigal

BioProtect Ltd is a leading medical start up in radiation protection technology. We offer spacers protecting healthy tissue during radiation oncology treatments, based on proprietary biodegradable balloon technology. The balloons suit a wide range of clinical applications in the fields of oncology and general surgery. The company’s first product, the BioProtect Balloon Implant, protects healthy tissue in patients undergoing radiation therapy for prostate cancer.

The opportunity:

In this job function, your primary role will be to support the process validation activities under the V&V team responsibility

In this position you will be asked to:

· Lead process validation (IQ/OQ/PQ) of equipment, systems, and processes; Write protocols and reports according to QMS and validation guidelines.

· Work closely and in coordination with engineering, production, and QA teams.

· Participate in design reviews of new or changed tooling, equipment, systems and processes.

· Establish validation impact assessment as part of engineering change control process.

· Follow up on the qualification testing execution in accordance with the protocols.

· Conduct product testing activities under defined conditions to verify/reject product specification using scientific methods.

· Support troubleshooting / investigating process validation related deviations.

· Develop, assess, and formalize instructions and forms for production

A successful candidate will have the following qualifications:

· 3 years of experience in design control/process 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

BioProtect is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.