Team Lead Validation
- ישראל
- משרה קבועה
- משרה מלאה
- 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.
- 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.
- 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).