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. Planning and managing engineering projects while complying with GMP and FDA, EMA regulations.

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