IT Lead Engineer

About the Department                                                                                                                                     

Novo Nordisk, a global health care company, is committed to discovering and developing innovative medicines to help people living with diabetes lead longer, healthier lives. To support this, Novo Nordisk is conducting research on stem cell therapy. Stem cell research raises hopes for improved treatment of Type 1 Diabetes and for future treatments with cell transplantation therapy. This treatment could be offered to people with many different serious chronic diseases caused by the degeneration of specific cells, such as Type 1 Diabetes. Type 1 Diabetes is manifested by the selective destruction of the insulin-producing cells in the body, which leads to a life-long dependence on insulin injections to control blood sugar levels. It is usually diagnosed in children and young adults. Cell therapy may offer a better treatment by replacing the lost cells with new insulin-producing cells derived from stem cells, thus avoiding daily multiple insulin injections as well as numerous blood glucose tests. This treatment may also offer better blood glucose control, which is crucial to avoid late-stage complications such as blindness and kidney failure. In this project Novo Nordisk will generate new stem cell lines to be used in future cell therapies to treat Type 1 Diabetes, Parkinson’s and chronical heart failure.  Are you ready to make a difference?

The Position

Cell therapy is a highly prioritized venture for Novo Nordisk, we work with the newest equipment and methods for producing cell therapy pharmaceuticals for the future. We are a dynamic team of engineers and scientists defining how to design and qualify facilities, equipment, and systems ready for GMP manufacturing. We pull resources with experience from other parts of Novo Nordisk to ensure that we adapt know-how and best practices successfully in establishing our facility. It is a great opportunity both for being part of defining something new and for gaining knowledge, know-how and best practices from an organization with proven track-record. We are looking for a Lead Engineer with responsibility for developing strategic goals and define objectives for IT infrastructure for Cell Therapy, CMC. 

Relationships

The IT Lead Engineer will work together with other highly dedicated engineers within IT, Automation, and validation, the Lead Engineer will report to the validation manager. The primary location is our Cell Therapy CMC Facility located in Fremont, CA. But you will work closely with internal stakeholders and colleagues in corporate Novo Nordisk A/S and Novo Nordisk Research Center Seattle, Inc. (NNRCSI).  Furthermore, you will have contact with external stakeholders such as vendors and service providers.

Essential Functions

• Take lead in deciding which systems and resources provide the best solutions to reach our CMC manufacturing goals. 
• Provide local coordination for Corporate IT systems Integration. 
• Develop strategic direction for Site Cell Therapy CMC IT and Automation Assets. 
• Evaluate advancements in the industry; implement new technologies that better serve business needs. 
• Recommend appropriate maintenance strategies to ensure uninterrupted systems usage and proper backup and recovery procedures to maintain current and future production requirements. 
• Manage comprehensive and proactive IT Compliance Strategy. 
• Continually analyze and assess potential IT security risks, develop plans to deal with such incidents by putting measures in place such as firewalls and encryption, monitoring and auditing systems for abnormal activities, and corrective actions. 
• Ensure strong alignment and synergies with IT practices and policies at Novo Nordisk Inc., Novo Nordisk A/S, and Cell Therapy CMC.     
• Follow all safety and environmental requirements in the performance of duties. 
• Perform all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations, and industry codes. 

Physical Requirements

0-10% overnight travel required.

Qualifications

• Bachelor’s Degree in a related field and Minimum of eight (8) years of IT experience within biotech industry or similar.  
• Minimum of four (4) years handling complex projects. 
• Excellent process improvement and problem-solving skills. 
• Knowledge of IT Compliance, preferably in a pharmaceutical manufacturing environment. 
• Excellent communication skills and ability to work in teams also required. 
• Strong computer skills including MS Office and SAP. 
• Skilled in use of computers, adapts to new technologies, keeps abreast of changes, learns new programs and processes quickly, uses computers to improve productivity. 
• A strong work ethic (self-motivated) and demonstrated ability to work in teams

Has demonstrated experience with:
•    CSV (following 21 CFR Part 11, preferably) 
•    ITIL (on the job experience or certification)
•    COBIT (on the job experience or certification)
•    IT Infrastructure integration 
 

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.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

The base compensation range for this position is $121,050 to $211,840. Base compensation is determined based on a number of factors.

Novo Nordisk requires all new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.