Team Lead Validation

Leading a team of validation engineers. • Responsible for validation of process equipment and supporting systems for the production of sterile media. • Writing and executing protocols and reports - IQ, OQ, PQ for equipment. • Full responsibility for Cleaning Validation - planning, execution and coordination with analytical laboratories. • Planning and managing engineering projects while complying with GMP and FDA, EMA (Ministry of Health) regulations. • Managing tasks, prioritizing and monitoring team schedules. • Ongoing interface with QA, operations, maintenance, production, laboratories and R&D departments. • Supporting the handling of exceptions, risk analysis and failure investigation. • Promoting continuous improvement and implementing new procedures and standards.

Job Description:
• Leading a team of validation engineers.
• Responsible for validation of process equipment and supporting systems for the production of sterile media.
• Writing and executing protocols and reports - IQ, OQ, PQ for equipment.
• Full responsibility for Cleaning Validation - planning, execution and coordination with analytical laboratories.
• Planning and managing engineering projects while complying with GMP and FDA, EMA (Ministry of Health) regulations.
• Managing tasks, prioritizing and monitoring team schedules.
• Ongoing interface with QA, operations, maintenance, production, laboratories and R&D departments.
• Supporting the handling of exceptions, risk analysis and failure investigation.
• Promoting continuous improvement and implementing new procedures and standards.

Job requirements:
• Bachelor's degree in engineering (chemical, biomedical, biotechnology, pharmaceuticals).
• At least 3 years of experience in validating process equipment - especially in a sterile environment.
• Deep familiarity with CIP/SIP cleaning processes including cleaning validation.
• Experience in writing protocols and IQ/OQ/PQ reports.
• Understanding of GMP regulations and regulatory requirements for sterile manufacturing systems.
• Management experience or leading teams/projects.
• Ability Working in a dynamic environment.

• Living in the northern region (Nahariya, Acre, Karmiel and the surrounding area).