About the Department
At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For nearly 100 years, we have led the way in diabetes care. As a result, our employees embark on life-changing careers with opportunities for mobility and growth within a global organization. At Novo Nordisk, you will work with the best manufacturing professionals in the industry.
Our new Active Pharmaceutical Ingredients (API) facility houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. Are you ready to help make what matters? Then, we are ready for you!
The purpose of the position is to operate utility and RMS process equipment to support DAPI-US production. Responsibilities include operations and maintenance of applicable equipment within the scope of the department. Other duties will include the development of SOPs, training and process improvements to support quality and financial goals for the site. Ensure establishing & maintaining positive working relationships with internal & external stakeholders and all activities are aligned with Environmental Health & Safety (EHS) program expectations.
- Work in a safe & environmentally responsible manner
- Operate equipment and processes following Standard Operating Procedures for both nGMP and GMP systems
- Prompt identification and documentation of system or operational anomalies for cause & clearance to minimize downtime and ensure a safe working environment
- Assist in maintaining standards & operational procedures for automated and manually operated systems
- Support consistent operation, maintenance & response for all control systems (BMS, PCS, Life Safety)
- Support stakeholders as required for successful plant operations including maintenance and optimization activities
- Execute raw material movement and offload into process systems
- Independently execute site rounds and equipment inspections to ensure efficient and compliant operations
- Adhere to all Quality & Environmental regulations
- Participate in systematic problem-solving efforts
- Manage individual training plan
- Responsible for routine cleaning and good housekeeping for assigned areas
- Real time review of electronic batch records ensuring compliance to Standard Operating Procedures (SOPs) & current Good Manufacturing Practices (cGMP) standards
- Other duties as assigned
- High school graduate or equivalent
- Minimum 2 years of related experience in regulated industry
- Computer literacy with associated systems
- BA/BS degree or higher in related field or equivalent education & experience
- BioWork or equivalent
- Knowledge & experience in the operations and maintenance of utility and raw material systems, as well as working in a regulated environment (FDA, cGMP, OSHA)
- Experience demonstrating a systematic approach to problem solving & troubleshooting based on data & facts. Actively participated in & driven event response activities. Documented problems & worked on ensuring rapid resolution & preventing recurrence
- Basic knowledge of production utility systems or raw material handling such as: purified water, process air, chemical storage & process waste systems
- Ability to work with electronic batch records, automated process equipment, and/or DeltaV or Syncade
- Ability to read/review equipment documents with a basic understanding
- Understanding of complicated product documentation & standard operating procedures with attention to high-level concepts
- Proven ability to check results & revise work tasks to meet daily plan
- Direct interaction in supporting stakeholders & potentially assisting with coordination of planned & corrective maintenance activities to ensure successful process turnaround/performance
Physical & Other Requirements
- Able to move equipment and/or supplies weighing up to 50 pounds within the facility
- Able to routinely operate & inspect manufacturing equipment using hands
- Able to remain in a stationary position up to 100% of the time
- Able to constantly position oneself to transfer materials within manufacturing environment
- Able to frequently move about the building to access other personnel & operational areas
- Able to move throughout the facility to interact with other employees in the normal office & manufacturing environment
- Corrected vision to 20/30 and/or ability to pass vision screening assessment necessary to procure motorized vehicle license
- Able to ascend/descend a ladder to service equipment
- Able to work atop elevated positions at heights
- Able to secure a motorized vehicle license & operate motorized equipment
- Able to work around odorous and/or hazardous materials
- Able to perform critical job functions in extremely cold work environments
- Able to work around mechanical equipment
- Able to work hours as needed to support production including on call, some evenings and/or weekends
- Able to position oneself within confined spaces for inspection, repair & maintenance of equipment
- Able to work in loud noise environments with hearing protection
- Able to work in & around an active construction site during project phase
- Able to travel internationally
- Able to attain clean room gowning certification
- Ability to work hours necessary to support production, including ability to stand on feet up to 12 hours or longer, day or night
Novo Nordisk requires all new hires, both Field and Office-based, to be fully vaccinated with a COVID-19 vaccine prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation for those unable to be vaccinated. You will be required to upload an image of your COVID-19 vaccine card at the time of hire and/or on your first day of employment.
At this time, Novo Nordisk is not currently hiring individuals for this position who now or in the future would require sponsorship for employment visa status.
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.
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.