Isolator Area Specialist

Are you motivated by driving innovation for the life-changing benefit of patients? Are you ready to help transform the treatment paradigm for a broad range of chronic diseases that currently rely on injection-based therapies? Then this is your moment. Apply now and join  Novo Nordisk. Together we can create life-changing innovation. Together we can make it happen.

The position             

Develops and manages new and existing projects by recommending, monitoring or adjusting appropriate plant operating procedures to meet program requirements within the manufacturing facility. Key areas of responsibility:

• Re-design Aseptic Filling Isolator fitting into FFEx MOC/STJ in compliance of ANNEX 1
• Implement EM isolator into Novo Nordisk manufacturing environment (full EBR)
• EM/Filling and Isolator project (Design facility/utility and Drive the installation and commissioning of isolator both in EM and filling, together with facility/utility areas)
• Aseptic Validation project (cycle development and validation of isolator & Aseptic Production Simulation)
• Develop and implement PUPSIT across Formulation, WS and filling
• Develop and implement RTP across WS, Direct Feed, EM and filling
• Direct project execution. Provide clear goals and purpose for the project and the project team members so that the project secures effective use of time and resources and builds employee motivation.  
• Create and develop the project plan. Create effective and transparent systems, structures and processes to drive the project so that the project secures clarity and order by applying the appropriate amount of planning and organising.                                                                                        
• In PS different project governance models exists. Below is listed the mandatory requirements for the different project types:  

1. cLEAN® project: Project brief. For 3-star projects enter the approved documents in I-Nexus. 
2. Investment project: Project Charter, Mandate and Agreement. Enter the approved documents in Clarity
3. Other project: Follow the local templates/guidelines.                                                                                       

• Monitor and control project work. Follow-up to keep end-product within scope, quality, schedule and budget so that the project delivers the desired end-product.                                                       
• Negotiate project resources with LoB management and manage these resources during project execution.  
• Establish the appropriate project governance together with the project owner, so that the project can be executed effectively and the outcome is sustained in the organization.                                     
• Report project performance to the relevant stakeholders.                                                   
• Perform integrated change control on the project. Evaluate changes to the project scope, schedule or cost in a coordinated manner so that all project constrains are evaluated.                                          
• Archive all key project data.   
• Close and evaluate the project.     
• Execute project to ensure compliance with NN Quality Management System and PS Environmental, Health and Safety Management system.                                                                            
• Lead the process of Project Portfolio Management, to ensure all projects in STJ are governed through the PPM model and aligned with site strategy and site business plan.                                           
• Establish and develop project management training to improve the overall capability of project management skill in STJ.                                                                       

Qualifications

• Bachelor or master’s degree in science, engineering, finance, logistics and supply chain management, business administration or other relevant background
• Education/training in GMP regulations, validation, LEAN and statistics
• Advanced English skills, international experience is preferable
• More than 10 years Aseptic manufacturing experience including isolator technology
• More than 10 years project management experience.
• Project management knowledge and has cross functional project management experience in NN is preferable
• Good communication skills, stronger interpersonal skills, observation ability and analytic capability
• Knowledge from a GMP/ISO 9001/ISO 13485 regulated production, working with requirements for validation and change procedure

Working at Novo Nordisk

At Novo Nordisk we recognise that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and the communities we operate in.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are happy to discuss flexible working, depending on the role and subject to business needs.

Are you motivated by driving innovation for the life-changing benefit of patients? Are you ready to help transform the treatment paradigm for a broad range of chronic diseases that currently rely on injection-based therapies? Then this is your moment. Apply now and join  Novo Nordisk. Together we can create life-changing innovation. Together we can make it happen.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.