Site Engineering Lead

Jul 28, 2021

Job Description

769 million. That’s how many lives are touched by Novartis products globally. And, while we’re proud of that fact, in this world of digital and technological transformation, we must ask ourselves this: how can we continue to improve and extend even more people’s lives?

The Site Engineering Lead 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.

General responsibilities will include but are not limited to the following:
• 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.); Perform other duties as assigned.

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:

• Bachelor’s degree in a technical discipline is required, a Master’s degree preferred.

• 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 is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
Millburn, NJ
Technical Operations
Full Time
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Site Engineering Lead

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