Process Development Engineer - DMD

About the Department

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 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 improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains.  Our newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products.  At API, you’ll join a global network of manufacturing professionals who are passionate about what they do.  

What we offer you:

• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance – effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• Family Focused Benefits including 12 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance 
• Life & Disability Insurance
• Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career.  Are you ready to realize your potential?  Join Team Novo Nordisk and help us make what matters.
 

The Position

Responsible for the design and implementation of manufacturing processes, instrumentation, and equipment start-ups from design phase through manufacturing scale. This individual provides expertise in engineering, design, validation, and scale-up.

Relationships

Manager.

Essential Functions

• Serve as Representative/Ambassador of Device Manufacturing Development (DMD) at the production sites, in relevant corporate departments, and at the equipment supplier
• Serve as Process engineer for new assembly line for medical devices
• Participate in process and equipment troubleshooting to support deviations, corrective actions, and related issues where DMD support is required
• Coordinate fabrication, procurement, installation, engineering start-up, and validation activities of new equipment and systems, including validation documentation  protocols, test executions, and summary reports
• Support global project execution according to the governance
• Participate in design and hazard reviews of plant expansions or process changes
• Participate in the development of new technology and ensure robustness of the assembly process and equipment, to include serving as point person for process improvement activities, such as performing or authoring equipment specifications, user and functional requirements specifications, and necessary Factory Acceptance Test (FAT) & SAT protocols
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations, and industry codes
• Follow all safety & environmental requirements in the performance of duties
• Other accountabilities, as assigned

Physical Requirements

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May required corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role.

Qualifications

• Bachelor’s degree in Engineering (preference on Mechanical), Biomedical, or a relevant field of study from an accredited university required
• Master’s degree in Engineering (preference on Mechanical), Biomedical, or a relevant field of study from an accredited university preferred
• Minimum of four (4) years of engineering experience in a GMP regulated environment required
• Excellent communication skills and ability to work in a high-paced team-oriented environment required
• Knowledge of Automation, GMPs, Compliance, and Regulatory requirements is required

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.

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.