Novartis Pharmaceuticals Corporation
San Carlos, CA
Areas of Expertise Desired:
Novartis in San Carlos is seeking a Process Unit Engineer Responsible for availability and reliability of equipment and instruments in the Process Unit. Drives preventive maintenance and calibration. Ensures modification to equipment is carried out according to change control procedures and qualified status is maintained. Leads mechanics and contractors in the execution of maintenance and capital expense projects.
• Ensure appropriate and effective technical support to the operation within the PU (e.g. changeovers, re-qualification) and the mechanics in the execution of maintenance work.
• Maintains as-built status of all GMP lifecycle documents. Performs Technical Change Control and maintains qualified status of equipment.
• Ensure all equipment, processes and systems achieve Global Quality Standards. En-sure work is compliant and to the required technical standards.
• Provide functional technical competence and knowledge in coordination and execution of maintenance and projects.
• Interface with specific 3rd parties as well as frontline support for craft/technician.
• Provides support to project teams in the preparation, review and approval of all qualifi-cation documents and activities.
• Reviews SOP’s and production batch records, ensuring all records are up to date and in compliance.
• Continuous improvement of engineering qualification processes.
• Conducts regularly GMP training for internal and external engineers.
• Ensure that all (internal, regulatory and statutory) QA, HSE and GPE relevant guidelines, directives and processes are adhered to.
• Establish and own equipment FMEAs together with Process Experts. Manage and im-prove risks identified in FMEAs.
• Analyze and communicate cost and failure trends. Propose continuous improvement projects.
• Ensure adherence to the Asset Care/Management Strategy and specifically in the following areas:
* Criticality and risk based approach to maintenance (maintenance plans, task lists and spare parts management) and optimized preventive maintenance.
* Consistent usage of Asset IT-Tools (e.g. CMMS/SAP-PM, Comos, e-calibration/CMS).
* Establish and maintain an improvement and Asset Care mentality across the site.
Bachelors degree in an Engineering discipline is required. Equivalent experience may be accepted. A minimum of 8 years industry work experience is required. A minimum of 5 years experience in a GMP operational or manufacturing pharmaceutical or other regulated environment. Knowledge of a process oriented organization and self-directed culture a plus. Sound knowledge of maintenance and operational processes. Proven project management and leadership skills of cross-functional teams. Interdisciplinary knowledge advantageous.
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