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

Requisition ID xxxx8BR
Title Process Engineer II : Cleaning Validation
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.
TITLE: PROCESS ENGINEER II : CLEANING VALIDATION
PURPOSE:
* To support the successful ramp:up of the CIP process for DAPI US. Provide input, review and approve Design and Requirement documents. Provide input, review and approve technical specifications.
* When established : drive and support the CIP process in the production department
ACCOUNTABILITIES:
* Overall CIP and cleaning validation responsible within production area
* Ensure quality of CIP equipment and processes in the production facilities
* Ensure development of and adherence to joint CIP strategy for the production facilities
* Ensure identification of and collaboration regarding interfaces to other processes and support systems in the project
* Creation of risk assessment documents, such as Requirement Risk Assessments (RRA's)
* Creation and participation in QRM risk assessments, such as Closed:Process, Contamination and Facilities flows
* Participation in design work shops with engineering suppliers
* Input, review and approval of Process Module Diagrams and Process Flow Diagrams
* Input, review and approval of Process Scheduling, Capacity Calculations and Equipment Sizing
* Input, review and approval of process Lay:Out diagrams
* Support project team in maintaining schedule adherence
* Ensure coordination and collaboration between project and other site stakeholders
* Gather and ensure knowledge transfer to project from similar production sites in Novo Nordisk
TECHNICAL COMPETENCIES:
* Education: BS (pharmaceutical science, chemical engineering, biochemistry or related field)
* Experience: 3:5+ years of experience from operating in a GMP regulated environment
* Technical/Process/Functional Knowledge:
* Specialist in CIP and cleaning validation processes, preferably within pharmaceutical production.
* Experience with API production, i.e. fermentation, recovery and purification processes.
* Experience with design of requirements documents for CIP equipment and units
* Experience setting acceptance criteria and carrying out cleaning validation.
* Experience with Process Control Systems.
* Knowledge of requirements/expectations from authorities e.g. FDA.
* Organization/Planning: Proven ability to establish and maintain networks and facilitate processes that encourage cross organizational knowledge sharing
BEHAVIORAL COMPETENC
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