Novartis Pharma Schweiz
Head of Engineering & Facilities (Associate Director)
Novartis Pharma Schweiz, Indianapolis, Indiana, us, 46262
Overview
Novartis, we are pioneering the future of cancer treatment through Radioligand Therapy (RLT) - a powerful fusion of nuclear medicine and precision oncology. As we expand our global RLT manufacturing footprint, we are seeking passionate, purpose-driven individuals to join our mission of delivering life-changing therapies to patients around the world. As the Head of Engineering & Facilities, you will lead the Indianapolis 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 Indianapolis Site Head and is a member of the Site Leadership Team.
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 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.
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, FDA, EMEA, 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 & Benefits The pay range for this position at commencement of employment is expected to be between $132,300 and $245,700 per year; however, while salary ranges are effective from 1/1/25 through 12/31/25 fluctuations in the job market may necessitate adjustments to pay ranges during this period. Final pay determinations will depend on various factors, including geographic location, experience, knowledge, skills and abilities. The total compensation package 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). Details of participation in these plans will be provided if an offer of employment is made. If hired, the 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 department performance, and market factors.
Additional Details
Seniority level:
Director
Employment type:
Part-time
Job function:
Engineering and Information Technology
Industries:
Pharmaceutical Manufacturing
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Novartis, we are pioneering the future of cancer treatment through Radioligand Therapy (RLT) - a powerful fusion of nuclear medicine and precision oncology. As we expand our global RLT manufacturing footprint, we are seeking passionate, purpose-driven individuals to join our mission of delivering life-changing therapies to patients around the world. As the Head of Engineering & Facilities, you will lead the Indianapolis 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 Indianapolis Site Head and is a member of the Site Leadership Team.
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 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.
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, FDA, EMEA, 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 & Benefits The pay range for this position at commencement of employment is expected to be between $132,300 and $245,700 per year; however, while salary ranges are effective from 1/1/25 through 12/31/25 fluctuations in the job market may necessitate adjustments to pay ranges during this period. Final pay determinations will depend on various factors, including geographic location, experience, knowledge, skills and abilities. The total compensation package 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). Details of participation in these plans will be provided if an offer of employment is made. If hired, the 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 department performance, and market factors.
Additional Details
Seniority level:
Director
Employment type:
Part-time
Job function:
Engineering and Information Technology
Industries:
Pharmaceutical Manufacturing
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr