Senior Engineer I - Facilities - GMP - Novo Nordisk

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

The Senior Engineer I will play a pivotal role in our state-of-the-art GMP facility.  In this position, you will be accountable for overseeing daily activities, utilizing data analysis for status reports, creating, and driving problem resolution plans and improvement projects. Your responsibilities will also include maintaining processes and ensuring the validated state of the facility operates within cGMP requirements, ensuring compliance with both internal and external guidelines. Additionally, you will be responsible for devising and implementing the overall cross-contamination strategy for the site.  The Senior Engineer I will be involved in crucial planning and coordination with both external vendors and suppliers, as well as internal stakeholders.  The position will require a proactive, detail-oriented individual with a strong background in engineering and a passion for maintaining high-quality standards.

Relationships

The Engineer – Facilities will work at the CMC Cell Therapy Manufacture facility located in Fremont, CA.  The Engineer – Facilities will report to a member of the Stem Cell Manufacture Leadership Team. Internal stakeholders include employees in Process Development, Manufacturing, Quality Assurance, Quality Control and Analytical Development at NN Fremont, employees at the Novo Nordisk Research & Development US, Inc. (NNRDUS) and Novo Nordisk Corporate office in Denmark. The Engineer – Facilities will help supervise facilities staff in the day-to-day performance of their job and drive compliance for the team. 

Essential Functions

• Oversee daily Facilities Team activities and supervise maintenance and facility activities
• Troubleshoot (ex. facility and equipment-related alarms)
• Utilize systematic problem-solving to identify compliance improvements
• Lead compliance improvements and ensure audit readiness
• Responsible for maintaining processes and ensuring compliance with internal and external metrology guidelines
• Author and drive Change Control (CR) and Deviation (DV) documentation
• Coordinate with other site teams to meet production plans and maintain facility uptime
• Track maintenance and calibration activities, overseeing scheduling, execution, and documentation review
• Contribute to shutdown planning, resourcing, and coordination
• Collaborate with outside service providers and maintain detailed records on calibration and maintenance
• Serve as a Subject Matter Expert for site and cross-functional teams
• Interface with site management for status reports, problem resolution plans, and improvement projects
• Assist in training new Facilities Team members
• Support special projects as assigned

Physical Requirements

Up to 10% overnight travel required.

Qualifications

• Bachelor’s degree required, Master’s degree, or PhD is preferred. 
  • A Bachelor’s degree with 5+ years’ relevant experience, or Master’s Degree with 3+ years’ relevant experience, or PhD with 0 years of experience can be considered
• Relevant experience includes:
  • Experience in GMP related field (pharmaceutical, biotechnology or medical device industry), ideally around 3 years within a regulated industry
  • Detailed understanding of GMP, GDP, deviations and nonconformance management and handling.
  • Ability to work on fast-paced, collaborative teams and demonstrate flexibility in response to changing priorities is a must.
  • Strong organizational, troubleshooting, communication and interpersonal skills are essential.
  • Demonstrated ability to work independently, in teams, and with external collaboration partners
  • Experience with metrology pertaining to maintenance/calibration required.
  • Required familiarity with facility systems BMS, HVAC
• Preferred experience includes:
  • 2 years’ experience working with CMMS systems (SAP or equivalent systems)
  • Knowledge in working with dashboards and establishing and monitoring KPI metrics
  • Supervisory experience
  • Knowledge of qualification and/or validation of systems/areas/equipment
  • Experience with cross contamination control strategies
• Demonstrated ability to work independently, in teams, and with external collaboration partners
• Ability to influence, communicate, and collaborate in teams spanning multiple time zones as part of a global organization
• Excellent written and oral communication skills
• Detail oriented with strong documentation skills

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.

This position is part of a job family. Title and level within the job family are evaluated based on a number of factors, such as years of experience, scope of work, proficiency, and business need. Candidates will be assessed for the most appropriate title and level within the job family during the recruitment process. The base range of pay for each title in this job family are as follows:

• Senior Engineer I - $100,000 to $140,000
• Senior Engineer II  - $135,500 to $150,000
• Lead Engineer - $150,000 to $185,000
 
In addition, this position is eligible for a company bonus based on individual and company performance.  
 
Novo Nordisk offers long-term incentive compensation depending on the position's level or other company factors.  
 
Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy. 

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.