US-NC, Process Eng III - Cleaning Validation Recovery Job 462447800A0-MZ
|Requisition ID 54739BR|
Title Process Eng III - Cleaning Validation Recovery
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.
To drive the successful ramp-up of the Clean In Place process for DAPI-US. Provide input, review & approve cleaning program documents. When established, drive & support the CIP process in the production department.
Overall CIP & cleaning validation responsible within production area.
Ensure quality of CIP equipment & processes in the production facilities.
Ensure development of & adherence to joint CIP strategy for the production facilities.
Ensure identification of & collaboration regarding interfaces to other processes & support systems in the project.
Ensure adherence &/or updating of risk assessment documents, such as Requirement Risk Assessments (RRA’s) & Quality Risk Management Documents (QRM‘s.)Input, review & approval of Process Scheduling, Capacity Calculations & Equipment Sizing.
Input, review & approval of process Lay-Out diagrams.
Support project team in maintaining schedule adherence.
Ensure coordination & collaboration between project & other site stakeholders.
Gather & ensure knowledge transfer to project from similar production sites in Novo Nordisk.
BA/BS (pharmaceutical science, chemical engineering, biochemistry or related field). MA/MS or higher preferred.
8+ years of experience from operating in a GMP regulated environment.
Technical/Process/Functional Knowledge: MANDATORY
• Specialist in CIP & cleaning validation processes, preferably within pharmaceutical production.
• Experience with API production, i.e. fermentation, recovery & purification processes.
• Experience with design of requirements documents for CIP equipment & units.
• Experience setting acceptance criteria & carrying out cleaning validation.
• Experience with Process Control Systems.
• Knowledge of requirements/expectations from authorities e.g. FDA.
Proven ability to establish & maintain networks & facilitate processes that encourage cross organizational knowledge sharing
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 ascend\descend 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 work 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 the hours necessary to support a 24/7 continuous manufacturing operation.
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.
Department DAPI US - Recovery
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