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Manufacturing Maintenance & Calibration Engineer

Company: Novartis Pharmaceuticals
Location: Millburn
Posted on: June 12, 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?

Lead maintenance, calibration 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:

  • 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 compliant maintenance of utilities/facilities with third party service providers; Provide oversight and/or perform equipment and systems qualification/validation, own change controls and oversight / implementation for local projects
  • Improve and develop manufacturing processes using statistical and empirical data; Issue/revise SOPs and protocols related to the manufacturing facility and equipment and implement global changes as required
  • Manage 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
  • 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

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What you'll bring to the role:

Education:

  • A Bachelors or Associates degree in a technical discipline is required

Experience & Requirements:

  • A minimum of 5 years of manufacturing experience in a regulated environment, in a maintenance/engineering capacity is required
  • Must be 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.)
  • Manage, plan and schedule compliant maintenance of utilities/facilities with third party service providers
  • Provide oversight and/or perform equipment and systems qualification/validation, own change controls and oversight / implementation for 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: https://talentnetwork.novartis.com/network

Keywords: Novartis Pharmaceuticals, New York , Manufacturing Maintenance & Calibration Engineer, Other , Millburn, New York

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