Process Engineer I / II - Cleaning Validation

About the Department

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For nearly 100 years, we have led the way in diabetes care. As a result, our employees embark on life-changing careers with opportunities for mobility and growth within a global organization. At Novo Nordisk, you will work with the best manufacturing professionals in the industry.

Our new Active Pharmaceutical Ingredients (API) facility houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. Are you ready to help make what matters? Then, we are ready for you!

Position Purpose

To support the successful ramp-up of the CIP process for DAPI-US.  Provide input, review & approve Design & Requirement documents.  Provide input, review & approve technical specifications.  When established – will drive & support the CIP process in the production department

Accountabilities

• 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
• Creation of risk assessment documents, such as Requirement Risk Assessments (RRA’s).
• Creation & participation in QRM risk assessments, such as Closed-Process, Contamination & Facilities flows.
• Participation in design work shops with engineering suppliers.
• Input, review & approval of Process Module Diagrams & Process Flow Diagrams.
• 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.

Required Qualifications

BA/BS in pharmaceutical science, chemical engineering, biochemistry or related field)

Desired Qualifications

• Experience 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.

Physical & Other Requirements

• Occasionally moves equipment and/or supplies weighing up to 50 lbs. within the facility
• Routinely operates & inspects manufacturing equipment using hands
• Must be able to be on feet for up to a 12-hour shift
• Constantly positions oneself to transfer materials within manufacturing environment. Frequently moves about building(s) to access other personnel & operational areas
• Corrected vision to 20/30 and/or ability to pass vision screening assessment necessary to procure motorized vehicle license
• Occasionally ascends/descends a ladder to access service equipment. Works atop elevated positions at heights
• Occasionally required to secure a motorized vehicle license & operate a motorized vehicle
• Occasionally works around odorous and/or hazardous materials
• Occasionally performs critical job functions in extremely cold work environments
• Occasionally positions oneself within confined spaces for inspection, repair & maintenance of equipment
• Ability to work in loud noise environments with hearing protection
• Ability to travel internationally, up to 10% of the time
• Ability to work in an open office environment with the possibility of frequent distraction
• Ability to work the hours necessary to support a 24/7 continuous manufacturing operation

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

Novo Nordisk requires all new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation.

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.