At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for an experienced Engineering Leader with previous experience in a GMP manufacturing environment to help us reach our ambitious goals. As the Site Engineering Head, you will lead the Millburn maintenance, calibration, project execution, and continuous improvement activities for manufacturing and major laboratory equipment, utilities, and facilities to establish consistent production output while keeping down-time to a minimum and improving reliability over time. This role reports directly into the Millburn Site Head and is a member of the Site Leadership Team.
About the Role
Key responsibilities:
- Provide leadership for the Millburn Site Engineering function. Manage a team of engineers, technicians, and external (3rd party) support. Manage departmental budgets.
- Ensure equipment availability for reliable product supply. Responsible for maintenance, calibration, and project execution programs which include planning and coordination of maintenance & calibration activities, project execution, and continuous improvement at site level for buildings, process equipment, utilities, and automation. Support global engineering programs and ensure compliance with local, regional, and global safety and regulatory requirements.
- Manage preventive maintenance, troubleshooting, corrective maintenance, calibration, and environmental monitoring in compliance with technical standards, SOPs, and applicable regulation.
- Provide oversight for equipment and systems qualification/validation, own change controls and oversight/implementation for local projects.
- Manage spare parts program including procurement of spare parts and equipment in line with established processes, ensuring availability for planned maintenance and unplanned repair.
- Provide radiation safety program support, responsible for calibration and functionality of all radiation detection equipment.
- Support and/or perform investigations/deviations from an engineering/maintenance perspective and own timely execution of resulting CAPAs. Own change controls for any equipment/facility/utility changes. Issue/revise SOPs as required.
Minimum Qualifications:
- Bachelor’s degree in a technical discipline.
- Minimum of 8 years of maintenance/engineering experience in a cGMP regulated environment including supervisory experience.
- Knowledge of and ability to adhere to all applicable procedures, cGMPs, company policies, and all Quality and Regulatory requirements.
- Prior experience in providing oversight and/or performing equipment and systems qualification/validation, owning change controls, and oversight/implementation of local projects.
- Advanced degree preferred.
- Prior experience in aseptic manufacturing and radiopharmaceutical processing preferred.
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: novartis-life-handbook.pdf.
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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