Process Engineer II : Fermentation Job - (clayton, north carolina) in Raleigh, North Carolina For Sale

Requisition ID xxxx5BR
Title Process Engineer II : Fermentation
Job Category Engineering
Job Description Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 39,700 people in 75 countries and markets its products in more than 180 countries.
To help meet growing demand for its diabetes treatments, Novo Nordisk expects to double production of its diabetes drugs over the next decade as the epidemic continues globally. Novo Nordisk is embarking on building a new factory, in Clayton, NC. The plant will employ 700 new workers to produce active ingredients for an oral version of a medicine called semaglutide and a range of other diabetes drugs.
Novo Nordisk is currently seeking to attract top talent in the Research Triangle Park area. This once in a life:time career opportunity is ideal for manufacturing professionals who understand not only the operational complexities of manufacturing, but have the desire and drive to help us design and build. Candidates interested in taking this journey will be required to spend time in our API Production facilities (located in Denmark), as well as 3:6 months at a South Carolina location. There you will work with some of the best manufacturing professionals in the industry : learning and taking part in the plant design. Travel will not be a long term requirement but will be expected over the first year.
Job Title : Process Engineer II : Fermentation
PURPOSE:
Process expert role in developing the project. Main tasks are:
* Provide input, review and approve Design and Requirement documents
* Provide input, review and approve specifications
ESSENTIAL FUNCTIONS:
* Overall validation responsible within area
* Support development of design: and requirement specifications documents
* Ensure quality of equipment and processes
* Creation of Fermentation process risk assessment documents, such as Requirement Risk Assessments (RRA's)
* Participation in the creation of a project cGMP Statement
* Creation and participation in QRM risk assessments, such as Closed:Process, Cross:Contamination, Contamination and Facility flows
* Input and review to Process FMECA's for Fermentation
* Participation in design work shops with engineering suppliers
* Input and review of Process Module Diagrams, and Process Flow Diagrams
* Input and review of Process Scheduling and Capacity Calculations
* Support package in maintaining schedule adherence
* Ensure coordination and collaboration between project and other site stakeholders
* Gathering and ensure knowledge transfer to project from DK sponsor site
* Other duties or tasks as assigned.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
* Education: BSc. in Engineering/related field or equivalent (experience + education)
* Experience: 5:8+ years engineering experience in Maintenance, Design, Process Improvement, cLEAN(R) 2 Star or Six Sigma Green Belt certification
* Technical/Process/Functional Knowledge: Knowledgeable in the following systems: Instrument and Electrical, Mechanical, Control/SCADA/PLCs, Process Improvement Methodologies, Root Cause Analysis (RCA), Reliability Centered Maintenance (RCM)
* Organization/Planning: Proven expertise in planning/organization/execution of maintenance activities, following up on results, and revising the work plan for complex problems being resolved by cross functional teams
PHYSICAL and OTHER REQUIREMENTS:
* Significant travel, up to 75 for the first year, some international
* Requires ability to move throughout the facility in the performance of duties in proximity of process equipment and areas
* Ability to work hours necessary and according to process needs
Nothing in this job description restrict
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