Lead Cleanroom Engineer

1 week ago

Kongens Lyngby, Lyngby-Tårbæk Kommune, Denmark Novo Nordisk AS Full time

Are you ready to contribute to the advancement of cutting-edge Fill & Finish facilities within a prominent global pharmaceutical organization? Are you passionate about pioneering and executing innovative technologies while challenging conventional practices? Do you possess expertise in cleanroom environments and maintaining exceptional quality standards?

If your answer is affirmative, you may be the Cleanroom Specialist we seek.

Position Overview

In the role of Senior Cleanroom Engineer, you will be instrumental in the design and implementation of cleanroom and modern production environments that guarantee optimal operational efficiency for our facilities.

Your responsibilities will include ensuring that the cleanroom solutions are at the forefront of technology upon entering production, adhering to current and future regulatory standards—creating a facility we can take pride in for decades to come.

Key Responsibilities

  • Design innovative cleanroom solutions for Novo Nordisk's future aseptic production environments.
  • Collaborate with technical teams to ensure critical functionalities and design principles are clearly articulated and documented.
  • Participate in vendor oversight throughout the design, construction, and testing phases.
  • Establish a risk-based approach to validation and maintain the validated state effectively.

This position will require collaboration with our global sites, and some travel is anticipated, estimated at five trips annually.

As a Cleanroom Specialist in Fill & Finish Expansions, you will be part of the EM, Cleanroom, and GMP team.

Our team comprises 15 professionals with diverse backgrounds, both professionally and personally. We value varied perspectives and experiences.

Qualifications

To excel in this role, we expect you to possess:

  • An academic degree in architecture, engineering, life sciences, or a related field.
  • A proven history of experience in GMP (Good Manufacturing Practices).
  • Over three years of experience with cleanroom processes and project involvement.
  • Experience in the qualification and commissioning of GMP facilities is advantageous.
  • Proficiency in verbal and written English.

As an individual, you naturally take initiative and possess a strong personal drive, a commitment to quality, and a desire to develop the optimal solutions while challenging the status quo. You thrive in dynamic environments and demonstrate meticulous attention to detail, employing a structured approach to problem-solving. Additionally, you have excellent stakeholder management skills, capable of building relationships on a global scale while embracing professional and personal diversity.

About the Department

You will be joining the Fill & Finish Expansions team, which is part of Product Supply, Quality & IT, employing approximately 28,500 individuals globally. Fill & Finish Expansions is a newly established and rapidly growing division responsible for designing, planning, and executing all major fill & finish expansion projects across PSQIT to meet the needs of millions of patients. We achieve this by reimagining our fill & finish facilities through modern technology. We are setting benchmarks for the future, designing facilities that we will continue to be proud of for many years to come. Fill & Finish Expansions adopts a global perspective, enabling you to work with multiple sites and cultures worldwide.

To discover more about Fill & Finish Expansions at Novo Nordisk, please visit our career site.

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