Job Description Summary

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.

Job Description

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.

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. (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.

Desirable Requirements:

Advanced degree
Prior experience in aseptic manufacturing and radiopharmaceutical processing

#LI-Onsite

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.

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.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings

Salary Range

$151,200.00 - $226,800.00

Skills Desired

Automation, Capital Expenditure, Change Management, Classification Systems, Critical Thinking, Efficiency, Flexibility, General Hse Knowledge , Including Gdp, Knowledge Of Gmp, Manufacturing Process (Production), Operations, Root Cause Analysis (RCA), Support Services