Senior Engineer I- Facilities Job in California (CA), Biology Career, Full Time Jobs in Novo Nordisk Inc.
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Life Science Career Fair

Senior Engineer I- Facilities job in Fremont

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Novo Nordisk Inc. jobs
California (CA), Fremont
Job Code:  297720-en_US
Employer:  Novo Nordisk Inc.
Category:  Biology
Job Type:  Full Time

Location
Country:  United States
State:  California (CA)
City:  Fremont
05/02/2024

Description
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 Engineer - Facilities will be responsible for driving maintenance and calibration activities for the Fremont site. They will act as both individual contributor as well as supervisory role for facilities team, and drive improvement projects for site compliance. Additionally, will drive some med-term planning activities and assist in coordination with manufacturing and support teams.

Relationships

The Engineer - Facilities will work at the CMC Stem Cell 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 Center Seattle, Inc. (NNRCSI) 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
  • The Engineer - Facilities will primarily be responsible for daily Facilities Team activities, maintaining and driving compliance improvements.
  • Ensure compliance to GMP and GDP practices. Mentor other team members on documentation practices and improvements.
  • Communicate and coordinate with other site teams to meet production plans and maintain high facility up time.
  • Review and suggest improvements to systems and methods/practices. Drive improvements in site facilities compliance.
  • Track all maintenance and calibration activities for team, providing oversight to scheduling, execution and documentation review.
  • Supports and contributes to shutdown planning, resourcing, and coordination.
  • Work with existing outside service providers (OSP's) and establish new providers as needed.
  • Keep and review detailed records on calibration and maintenance activity.
  • Author and drive both Change Control (CR) as well as Deviation (DV) documentation for facilities related activities. Demonstrate consistent improvement in key metrics for team.
  • Act as Subject Matter Expert (SME) for site and/or cross-functional teams.
  • Interface with site management team for status reports, problem identification/resolution plans, and improvement projects.
  • Assist in training of new hires for the Facilities Team.
  • Provides support to Facilities Team in day-to-day activities.
  • Perform & support special projects as assigned.

Physical Requirements

0-10% overnight travel required.

Qualifications
  • Bachelor's degree in engineering or related field.
  • 5 or more years relevant experience required.
  • Must have a minimum of 3 years of experience in GMP related field (pharmaceutical, biotechnology or medical device 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
  • Required familiarity with facility systems BMS, HVAC.
  • A minimum of 2 years' experience working with CMMS systems (SAP or equivalent systems) preferred.
  • Knowledge in working with dashboards and establishing and monitoring KPI metrics preferred.
  • Managerial experience is preferred.
  • Experience with validation of systems/areas/equipment is preferred.
  • 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.

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.
ref: (297720-en_US)
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