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API Manufacturing Associate III -(Recovery Track) at Novo Nordisk in Clayton, North Carolina

Posted in Other 12 days ago.

Type: Full Time

Job Description:

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?

Position Purpose

Operate API manufacturing equipment to achieve production goals.


* Work in a safe & environmentally responsible manner

* Follow instructions listed in GMP documentation & product quality

* Review Standard Operating Procedures (SOP's) & other documents, as required

* Real time review of electronic batch records ensuring compliance to Standard Operating Procedures (SOPs) & current Good Manufacturing Practices (cGMP) standards

* Manage individual training plan

* Participate in qualification & validation activities as required

* Setup, operate, monitor, & control highly automated processes & systems

* Execute production schedule to achieve production goals

* Utilize investigation skills during troubleshooting & assist during equipment maintenance, including restoration of lost function, predictive & preventative maintenance

* Maintain clean room areas & perform environmental monitoring, as required

* Record/review production data in BPR, logbooks & other associated forms & review all data for entire team. Ensure all errors are addressed & corrected real time ensuring compliance with cGMPs

* Other accountabilities, as assigned

Required Qualifications

* High school graduate or equivalent

* Computer literacy including, but not limited to the ability to operate computer driven manufacturing/production equipment & efficient use of Microsoft Office suite programs

Desired Qualifications

* BA/BS degree or higher in related field &/or a minimum of 5 years of experience in a Food & Drug Administration (FDA) regulated manufacturing industry

* BioWork or equivalent

* Experience with Fermentation, Centrifuges, Chromatography or similar equipment preferred

* 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 biology/chemistry

* Ability to read, write & understand complicated product documentation & standard operating procedures with attention to detail

* Ability to perform basic material handling tasks & safely & effectively use material handling equipment

* Experience with electronic batch records, automated process equipment, &/or DeltaV or Syncade

* 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 ascenddescend 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

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.