US-NC, Process Engineer III - Fermentation Job 440006900A2-MZ
|Requisition ID 51496BR|
Title Process Engineer III - Fermentation
Job Category Engineering
Your Groundbreaking Journey
At Novo Nordisk, we want to make a difference. For more than 90 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 and improve the quality of life for millions of people around the world.
To help meet the growing demand for our diabetes treatment, Novo Nordisk expects to double production of diabetes drugs over the next decade. Novo Nordisk is currently building a new diabetes API plant in Clayton, NC next to our existing facility that employs 800 people. The new plant will initially employ 700 employees to produce the active ingredients for a new diabetes oral treatment and a range of other diabetes drugs.
Novo Nordisk is currently seeking top talent for this green field project and eventual operations. This once in a life-time career opportunity is ideal for manufacturing professionals who not only understand the operational complexities of manufacturing but also have the desire and drive to help us design and build. Here you will work with the best manufacturing professionals in the industry, while learning and taking part in the plant design.
Ensure successful qualification & execution of the project phases for the Fermentation process, evolving into a process subject matter expert for the Fermentation area.
Main tasks include:
• Lead team in ensuring installed design adheres to process requirements.
• Coordinate & execute process validation activities.
• Provide technical support of the operating facility to meet business goals.
• Coach & mentor other members of the process engineering team.
* Overall validation responsible within area.
* Execute & coordinate all qualification activities included in the project (FAT, SAT, IQ, OQ, PQ).
* Lead / provide technical support to investigation & resolution of VNC’s & NC’s.
* Support development & implementation of change requests during commissioning & operation.
* Verify process equipment & facilities satisfy design requirements. Ensure designs comply with current pharmaceutical standards applicable for the project such as ASME BPE, GAMP, cGMP, ISPE guidelines.
* Gathering & ensure knowledge transfer to project from DK sponsor site.
* Support work packages in maintaining schedule & project milestone adherence.
* Ensure coordination & collaboration between project & other site stakeholders.
* Ensure design adheres with process FMECA's & resolve misalignments where observed.
* Participation in design / progress reviews with engineering suppliers. Drive solutions to resolve issues & provide recommendations to project.
* Develop expert knowledge of process risk assessment documents such as requirements risk assessments (RRA's).
* Support update, development & design adherence to requirement specification documents.
* Participation in review & update of QRM risk assessments such as closed-system, cross-contamination, contamination & facility flows.
* Apply Fermentation expertise to the review & update of design documentation (process flow diagrams, P&IDs, etc.).
* Provide design basis information for accurate process scheduling & capacity calculations.
* BA/BS in chemical engineering, biology or other pharmaceutical related field.
* 8-15+ years engineering experience in operations, process design/troubleshooting/improvement & reliability centered maintenance.
* Six Sigma Green Belt certification/cLEAN® 2-star desired.
* Considerable experience of working with cGMPs & their applications.
* Demonstrated expertise in Fermentation processes.
* Knowledgeable in the following systems: Instrument & Electrical, Mechanical, Control/SCADA/PLCs, Process Improvement Methodologies, Root Cause Analysis (RCA), Reliability Centered Maintenance (RCM).
Physical & Other Requirements:
* Ability to work in & around an active construction site during project phase.
* Ability to work in confined spaces, near operating equipment, & in loud noise environments.
* Ability to travel internationally.
* Ability to work hours necessary to support production & maintenance activities.
• Ability to independently apply advanced engineering techniques & analysis within the discipline.
• Strong project management skills.
• Excellent oral & written communication skills.
• Proven expertise in planning/organization/execution of maintenance activities & following up on results.
• Creating &/or revising the work plan for complex problems being resolved by cross functional teams.
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.
Department DAPI US - Fermentation
Position Location US - Clayton, NC
State/Provinces US - NC
Job/Position Country US
At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle – helping us find the right balance between compassion and competitiveness
With a career at Novo Nordisk, you’ll feel a difference right from the start. It’s a sense of inspiration and mobility that comes from a shared belief in driving positive change for people, families, and communities everywhere. Congratulations on taking your first step!
Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Please visit our website at www.novonordisk.com