349446BR
Jul 29, 2022
USA

Job Description

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!

The Site Engineering Head will lead the Millburn maintenance, calibration, project execution and continuous improvement activities for the Millburn 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.

Your responsibilities include, but are not limited to:

• Provide leadership to the Millburn Site Engineering function with responsibility for the 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.
• Manage a team of engineers, technicians and external support to maintain the site manufacturing and major QC equipment as well as facilities and utilities compliant with local, regional and global safety and regulatory requirements and ensure equipment availability for reliable product supply.
• Manage / perform / plan and ensure manufacturing / major laboratory equipment preventive maintenance according to plan, troubleshooting, corrective maintenance, calibration and environmental monitoring in compliance with technical standards, SOPs and applicable regulation.
• Manage, plan and schedule third party service providers; Provide oversight and/or perform equipment and systems qualification/validation, own change controls and oversight / implementation for local projects
• Manage departmental budgets.
• Support global engineering programs and own the local deployment, e.g. CMMS, EMS systems.
• Issue/revise SOPs and protocols related to the manufacturing facility, equipment and procedures, implement local and/or global changes as required.
• 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.
• Evaluate, in conjunction with QA, the requirement for change control assessment/process for any equipment/facility/utility changes and own change controls in area of responsibility.
• Improve and develop manufacturing processes using statistical and empirical data.
• Support and/or perform investigations / deviations from an engineering/maintenance perspective and own timely execution of resulting CAPAs in area of responsibility; Adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.)

Diversity & Inclusion / EEO

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.

Minimum Requirements

What you'll bring to the role:

Bachelors degree in a technical discipline is required, Masters degree preferred.

Experience & Requirements:
• A minimum of 8 years of manufacturing experience in cGMP regulated environment, in a maintenance/engineering capacity is required.
• Must be knowledgeable of and able to adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.).
• Experienced to manage, plan and schedule compliant maintenance of utilities/facilities with third party service providers.
• Prior experience in providing oversight and/or performing equipment and systems qualification/ validation, owning change controls and oversight / implementation of local projects

Why Advanced Accelerator Applications (AAA)?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications (AAA), a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity, and inclusion. 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 [email protected] 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.

While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated.This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected].

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
ONCOLOGY
ADVANCED ACCELERATOR APPLICATIONS
USA
Millburn, NJ
Technical Operations
Full Time
Regular
No
careers default image
349446BR

Site Engineering Head

Apply to Job Access Job Account