Site Engineering Head

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.
• 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. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.).
• Prior experience in providing oversight and/or performing equipment and systems qualification/ validation, owning change controls and oversight / implementation of local projecs.
• Advanced degree
• Prior experience in aseptic manufacturing and radiopharmaceutical processing

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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.

The pay range for this position at commencement of employment is expected to be between $ 151,200 and $226,800 per year; however, while salary ranges are effective from 1/1/24 through 12/31/24 fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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