Work Schedule Standard (Mon-Fri) Environmental Conditions Office Lead and handle technology transfer projects from the develop phase to execution, validation, and project closure.
- Act as primary technical interface between internal teams, external clients, and equipment suppliers. - Be responsible for the development, installation, and commissioning of process equipment and systems in compliance with GMP requirements. - Coordinate engineering activities to ensure timely and successful project delivery. - Handle modifications and upgrades of existing GMP equipment to align with new process requirements. - Prepare and review project documentation, including URS, design specifications, risk assessments, and validation protocols (IQ/OQ/PQ). - Ensure compliance with regulatory, quality, and safety standards throughout all project stages. - Support process optimization and fixing activities during and after project implementation. - Collaborate with multi-functional teams (Process, Quality, Validation, Maintenance, and Production). - Monitor project budgets, schedules, and prioritization, reporting progress to management and clients. - Ensure accurate management of CAPAs and Change Control in accordance with business strategies and quality requirements.