Novartis HEOR Fellowship Program
Head of Engineering & Facilities (Associate Director)
Novartis HEOR Fellowship Program, Indianapolis, Indiana, us, 46262
Head of Engineering & Facilities (Associate Director) – Indianapolis, IN
At Novartis, we are pioneering the future of cancer treatment through Radioligand Therapy (RLT) and are expanding our global RLT manufacturing footprint. We are seeking a passionate, purpose-driven leader to join our team and help deliver life-changing therapies to patients around the world.
The Head of Engineering & Facilities will lead the Indianapolis maintenance, calibration, project execution and continuous improvement activities for manufacturing and major laboratory equipment, utilities and facilities. The role aims to establish consistent production output, minimize downtime, and improve reliability over time. This position reports to the Indianapolis Site Head and is a member of the Site Leadership Team.
Key Responsibilities
Provide leadership for the Indianapolis 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, including planning and coordination of maintenance & calibration activities, project execution and continuous improvement 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 regulations.
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.
Qualifications
Essential Requirements
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 (e.g., 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 projects
Desirable Requirements
Advanced degree
Prior experience in aseptic manufacturing and radiopharmaceutical processing
Compensation and Benefits The pay range for this position at commencement of employment is expected to be between $132,300 and $245,700 per year; however, salary ranges may be adjusted during the period. The total compensation package may include a sign-on bonus, restricted stock units, discretionary awards, and a full range of medical, financial, and other benefits (including 401(k) eligibility and various paid time off benefits). Details of participation will be provided if an offer is extended. The role may be at-will and base salary and other compensation programs may be modified at the Company’s discretion.
Why Novartis Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people who collaborate, support and inspire each other to achieve breakthroughs that change patients’ lives.
EEO Statement The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position, please contact us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and include the job requisition number.
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The Head of Engineering & Facilities will lead the Indianapolis maintenance, calibration, project execution and continuous improvement activities for manufacturing and major laboratory equipment, utilities and facilities. The role aims to establish consistent production output, minimize downtime, and improve reliability over time. This position reports to the Indianapolis Site Head and is a member of the Site Leadership Team.
Key Responsibilities
Provide leadership for the Indianapolis 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, including planning and coordination of maintenance & calibration activities, project execution and continuous improvement 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 regulations.
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.
Qualifications
Essential Requirements
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 (e.g., 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 projects
Desirable Requirements
Advanced degree
Prior experience in aseptic manufacturing and radiopharmaceutical processing
Compensation and Benefits The pay range for this position at commencement of employment is expected to be between $132,300 and $245,700 per year; however, salary ranges may be adjusted during the period. The total compensation package may include a sign-on bonus, restricted stock units, discretionary awards, and a full range of medical, financial, and other benefits (including 401(k) eligibility and various paid time off benefits). Details of participation will be provided if an offer is extended. The role may be at-will and base salary and other compensation programs may be modified at the Company’s discretion.
Why Novartis Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people who collaborate, support and inspire each other to achieve breakthroughs that change patients’ lives.
EEO Statement The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position, please contact us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and include the job requisition number.
#J-18808-Ljbffr