Process Engineer III - Manufacturing Science, MSAT

About the Department

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. 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 Emerging Technologies -Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

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

A new department is being created to improve system & equipment reliability for the core processes to meet all customer, business & regulatory requirements through focus on people, process, & equipment and serving as the gatekeeper for all related standards. In addition, this new position will oversee the product technical lifecycle management with regards to process control strategy (post-approval) process/yield improvement, process knowledge management, batch deviations, and ensuring accuracy of regulatory CMC registration detail. Support relevant inspections, including direct interaction with regulatory agencies during site inspections. Serve as the SME lead for review and approvals of deviations, Out of Specifications, change controls and corrective and preventative actions. Develop process control strategy documents, technology transfer change controls, engineering, clinical, and PPQ batch protocols in coordination with OPDev or other MSAT areas globally.

Relationships

OFP Supervisors, Managers and Directors.

Essential Functions

Coach & mentor peers and Engineers

Support technical development of Process Engineers, Maintenance Technicians & Technical Area Specialists

Lead process improvement projects with cross-functional teams, to include use of Six Sigma Black Belt concepts

Lead best practice research & leverage findings across site, to include implementation and sharing knowledge across all sites to support improvement efforts

Serve as system and process expert for site

Manage schedule & budget for capital projects

Support event response activities, to include (list what these are)

Maintain & establish standards for procedures & maintenance plans

Follow all safety and 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 require 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 or related field of study from an accredited university required

Minimum of eight (8) years of engineering experience in Maintenance, Design, Process Improvement, Six Sigma Black Belt certification or equivalent required

Knowledgeable in the following systems: Instrument and Electrical, Mechanical, Control/SCADA/PLCs, Process Improvement Methodologies, Root Cause Analysis (RCA), Reliability Centered Maintenance (RCM) preferred

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-***. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.