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Associate Process Engineer - API

Company: Novo nordisk
Location: clayton
Posted on: May 3, 2021

Job Description:

About the DepartmentAt 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 PurposeEnsure successful ramp-up of the process tracks. Process expert role in developing the project. Primary tasks: provide input, review & approve design & requirement documents; provide input, review & approve technical specifications.AccountabilitiesSupport development of design & requirement specifications documentsEnsure quality of equipment & processesSupport the creation of process tracks risk assessment documents, such as Requirement Risk Assessments (RRA's)Participation in the creation of a project cGMP StatementCreation & participation in QRM risk assessments, such as Closed-Process, Cross-Contamination, Contamination & Facility flowsInput & review to Process FMECA's for the Process tracksParticipation in design work shops with engineering suppliersInput & review of Process Module Diagrams, & Process Flow DiagramsInput & review of Process Scheduling & Capacity CalculationsSupport package in maintaining schedule adherenceEnsure coordination & collaboration between project & other site stakeholdersGathering & ensure knowledge transfer to project from DK sponsor siteOther duties or tasks, as assignedRequired QualificationsBA/BS in Science or Engineering (preferably Mechanical, Electrical, Chemical or Industrial), or an equivalent combination of education & related experience in a GMP environment for more than five (5) years.Desired QualificationsMinimum of one (1) year of work-related engineering experience in Manufacturing, Design, Maintenance or Process ImprovementKnowledgeable in the following systems: Instrument & Electrical, Mechanical, Control/SCADA/PLCs, Process Improvement Methodologies, Root Cause Analysis (RCA), Reliability Centered Maintenance (RCM)Proven expertise in planning/organization/execution of maintenance activities, following up on results & revising the work plan for complex problems being resolved by cross functional teamsPhysical & Other RequirementsOccasionally moves equipment and/or supplies weighing up to 50 pounds within the facility using various body positionsRoutinely operates & inspects manufacturing equipment using handsAbility to be on feet for up to a 12-hour shiftCorrected vision to 20/30Occasionally ascends/descends a ladder to service equipment & can work atop elevated positionsOccasionally works around odorous and/or hazardous materialsMay be required to wear latex glovesAble to work in loud noise environments with hearing protectionAble to work for short periods of time with respiratory protectionAble to travel internationally, up to 25% of the timeAble to work in an open office environment with the possibility of frequent distractionAble to work the hours necessary to support a 24/7 continuous manufacturing operationNo relocation is available for this role.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 statusNovo 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.

Keywords: Novo nordisk, Raleigh , Associate Process Engineer - API, Other , clayton, North Carolina

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