About the Department
At Novo Nordisk, we want to make a difference. For more than 95 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. Help us bring quality to life. Working at our Diabetes Active Pharmaceutical Ingredient (DAPI) manufacturing facility you will help meet the growing demand for our treatments. Novo Nordisk expects to double production of diabetes and obesity drugs over the next decade and are currently building a new 825,000 sq. ft diabetes Active Pharmaceutical Ingredient (API) plant in Clayton, NC next to our existing “fill and finish” manufacturing facility. Our new $2 billion API facility is expected to be operational in 2020, with 700 full-time employees responsible for the fermentation, recovery and purification of insulin and GLP1 ingredients. This once in a life-time career opportunity is ideal for pharmaceutical manufacturing professionals who not only understand the operational complexities of manufacturing but also have the desire and drive to help us build, validate, and run our processes. Here, you will work with the best manufacturing professionals in the industry. Are you ready to make a difference?
Level and Salary commensurate with experience.
The purpose of this position is to contribute to the establishment of all clean utilities systems for the DAPI-US facility. Responsibilities include, but are not limited to: writing/reviewing specification; design reviews & design qualifications; equipment installation; acceptance testing & qualification; SOP development; maintenance development & training; management of cost, quality & schedule within area of responsibility; establishing & maintaining positive working relationship with internal & external engineering team & stakeholders. All activities are aligned with Environmental Health & Safety (EHS) program requirement.
- Create & maintain system specifications for clean utilities.
- Support all design, installation, acceptance testing, qualification, training activities, etc. for clean utilities.
- Provide additional technical support to project team as required.
- Adhere to all quality & environmental regulations within area of responsibility.
- Support technical development of Facilities Technicians in preparation for Transfer of Care, Custody & Control (TCCC).
- Continuous process improvement using cLEAN® concepts.
- Maintain & establish standards for procedures & maintenance plans.
- All safety & environmental requirements in the performance of duties.
- BA/BS in mechanical, electrical or chemical engineering or equivalent combination of education & experience
- 2-5+ years engineering experience in a manufacturing facility or pharmaceutical/biotech project.
- Knowledgeable in clean utilities system to include: Purified Water, Clean Steam, Process Air, Nitrogen, HVAC, etc.
- Knowledgeable in black utilities system to include: chilled water, plant steam, compressed air, vacuum, waste water, etc.
- Ability to read/review design drawings with a basic understanding of P&ID, HVAC, electrical systems, etc.
- Understanding of technical documents such as URS, SAT, FAT, Validation Protocols.
- Understanding of complicated product documentation & standard operating procedures with attention to high-level concepts.
- Computer literacy with associated systems.
- Knowledge & experience in the operations, maintenance, & design of cGMP utilities as well as working in a regulated environment (FDA, cGMP, OSHA).
- Proven expertise in planning/organization/execution of project & maintenance activities, following up on results, & revising the work plan for complex problems being resolved by cross functional teams.
- Ability to work in & around an active construction site.
- Requires ability to move throughout the facility in the performance of duties in proximity of process equipment & areas.
- Ability to work hours necessary & according to customer needs.
- Domestic & International travel as required.
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.
Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.
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.