Engineer - Automation And Validation

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

Do you want to part of the team that implementing automation solution in newly established facility for producing cell therapy products for clinical trials? You will be responsible for participate, drive and oversee activities related to automated solutions for cGMP regulated manufacturing. You will be an integral part of our team ensuring that the facilities, systems, and equipment are designed in compliance, kept updated and in validation state during the life cycle. 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.

**Open to hiring at a more senior level commensurate with experience**

Relationships

You work together with other highly dedicated validation engineers and will report to a validation manager. The primary location is our Cell Therapy Manufacturing Facility located in Fremont, CA. You will also work with internal stakeholders and colleagues in Novo Nordisk global headquarters, Novo Nordisk Research Center Seattle, Inc. (NNRCSI) and Novo Nordisk Quality. Furthermore, you will have close contact with external stakeholders as vendors and service providers.

Essential Functions

• Prepare documentation according to NN procedures, guidelines, and regulatory requirements to ensure that the automation solution is complying, hereunder: Test protocols and reporting, risk assessments, SOP’s and rationales.Ensure that automated equipment and systems are kept in a validated state during the life cycle and prepare the required documentation.
• Qualification planning, design review and tests including FAT/SAT of automated equipment for GMP use.
• Drive stakeholder discussions, conclusions and decisions in Stakeholder meetings.
• Ensure good energy in collaborative work with other engineers and researchers from other disciplines and teams
• Implementation and qualification of automated equipment/processes.

Physical Requirements

0-10% overnight travel required.

Qualifications

• Knowledge with liquid handler or similarly automated processes is preferred.
• Excellent time management and organizational skills (schedules, timelines, task prioritization), with the ability to adapt to changing priorities.
• Highly motivated and comfortable working in a results-oriented dynamic research and development environment.
• Knowledge and/or professional experience is preferred in the pharmaceutical industry, healthcare industry, regulated medical device development, or another regulated field
• Experience with writing, and execute documentations (SOP’s, Protocols, Plans and Reports).
• Relevant experience includes:
  • Experience with implementing and qualifying automated equipment/processes.
  • Experience with writing, and execute documentations (SOP’s, Protocols, Plans and Reports).
  • Ability to demonstrate broad understanding of: Concepts of Validation, change control processes, Root cause analysis techniques and cGMP documentation practices, cGMP regulations, GMP and other industry standards pertaining to validation.
  • Excellent time management and organizational skills (schedules, timelines, task prioritization), with the ability to adapt to changing priorities.
  • Excellent multi-tasking and problem-solving skills; solution-oriented; self-motivated.
  • Highly motivated and comfortable working in a results-oriented dynamic research and development environment.
  • Ability to work independently and in teams consisting of members with different degrees of knowledge or ability.
• Detail oriented with excellent written and oral communication skills
• Ability to work independently and in teams consisting of members with different degrees of knowledge or ability.
• Demonstrated ability to work independently and in teams
• Ability to demonstrate broad understanding of: Concepts of Validation, change control processes, Root cause analysis techniques and cGMP documentation practices, cGMP regulations, GMP and other industry standards pertaining to validation.
• Hands-on knowledge of working in a cleanroom environment, manufacturing or knowledge of equipment use for cell therapy is preferred.
• Experience with implementing and qualifying automated equipment/processes.
• A Bachelor’s degree with 4+ years’ and Master’s degree with 2+ years’ relevant experience can be considered; Minimum of High School Diploma with 7+ years relevant experience required.
• Bachelor’s degree preferred. Degree within engineering discipline preferred
• Excellent multi-tasking and problem-solving skills; solution-oriented; self-motivated.

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 $80,670 to $172,940. This range is part of a family of roles and this role can be leveled up commiserate with experience.

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.