The person will establish a validations team and will report directly to the COO.
This role will work closely with the production, engineering, R&D and quality teams.
The validation Engineer will manage, inspect, test, and modify the instrumentation, equipment and procedures used for manufacturing, testing and inspection of company products.
Support the testing and validation of new designs to meet or exceed internal and external requirements.
Will take charge of leading all the: process validations / equipment validation / design verification / validations with sub-contractors and others.
Primary responsibilities will include:
· Directing validation activities, promoting company validation strategy including planning, implementation and monitoring of VMP.
· Analyzing and documenting test results
· Monitoring and testing equipment
· Lead the process of PFMEA
· Providing evidence of regulatory compliance
· Help to establish manufacturing inspection, sampling and statistical process control methods, and procedures to assure quality of manufactured products.
· Assures compliance to in-house and external specifications and standards.
· Maintain quality assurance objectives.
· Investigate acauses of equipment failures and anomalies and decide if equipment needs to be repaired or replaced.
· Write, review and approval of company document's, specifications, validation protocols and reports.
· Performs other assignments as required by management
· Contributes to process improvements. Work closely with production and logistics teams,interfaces with manufacturing in identifying and correcting quality issues for new and existing product lines.
Education / Experience /Skills:
· A diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study, life-science, medicine, pharmacy, engineering, or another relevant discipline.
· Knowledge in the field of medical devices/pharmaceuticals and or life- science and at least two (3) years of professional
· Experience of 3 years in validation testing and statistical analysis.
· Proficiency in MS-Office and ERP systems
· Must have excellent reading, writing and communication skills in English and Hebrew.
· Analytical thinking
· Good communication skills
· Excellent reporting, teamwork, and time management skills
· Ability to learn quickly, analyze problems, work independently, and organize and execute multiple work tasks
· Ability to read and interpret engineering drawings, product specifications, procedures, and standards Excellent written, oral communication and technical documentation writing skills.