Process Engineer II - EPR (Form/W&S, INSP) - Days (M-F)

About The Department

At Novo Nordisk, we want to make a difference. 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 legacy Injectable Finished Products (IFP) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At IFP, 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 positionsAll employees enjoy generous paid time off including 14 paid holidaysHealth Insurance, Dental Insurance, Vision Insurance – effective day oneGuaranteed 8% 401K contribution plus individual company match optionFamily Focused Benefits including 12 weeks paid parental & 6 weeks paid family medical leaveFree access to Novo Nordisk-marketed pharmaceutical productsTuition AssistanceLife & Disability InsuranceEmployee 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 the laboratory through manufacturing scale. This individual provides expertise in cell culture, purification, freeze drying, formulation, powder processing, engineering, design, and scale-up.

Relationships

Reports to: According to the organizational chart

Number of subordinates with direct/indirect referral: n/a

Essential Functions

Leads process and equipment troubleshooting to support deviations, corrective actions and related issuesCoordinate fabrication, procurement, installation, engineering start-up, and validation activities of new equipment and systems, including documentation of IQ/OQ protocols, test executions, and summary reportsParticipate in the development and implementation of procedural or automation improvement changesParticipate in design and hazard reviews of plant expansions or process changes, and serving as the technical point of contact or user representative for contractor services including design, fabrication, installation and validationPoint person for process improvement activities; including performing or authoring equipment specifications, user and functional requirements specifications, and necessary FAT and SAT protocolsInitiate and manage projects, tracking spending of budgets, creating scope of work, justification, risk assessments, cost estimates, implementing purchase order requisitions, and controlling payment schedulesRegular supervision of contractor or intern reports including mentoring, performance reviews, project and support advice as well as troubleshooting for the more complicated issues found in the manufacturing environmentPerforms all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codesIncorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with othersIncorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others

Physical Requirements

0-10% overnight travel required. The ability to climb. stoop, kneel, crouch, crawl, reach, stand, and walk. The ability to push, pull, lift, finger, feel, and grasp. The ability to speak, listen, and understand verbal and written communication. Repetition including substantial movement of wrists, hands, and or fingers. Lifting up to 33lbs/15kg of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects. Visual acuity to perform close activities such as: reading, writing, and analyzing; and visual inspection. The working environment includes a variety of physical conditions including: noise, inside and outside conditions, working in narrow aisles, and temperature changes; atmospheric conditions including: odors, fumes, and dust.

Qualifications

Requires a Bachelors/Masters/PhD degree (or equivalent experience) in engineering or related disciplineA minimum of six (6) years related experience. Prefer medium to large scale pharmaceutical or biotechnology process experienceNormally receives no instructions on routine work, general instructions on new assignmentsKnowledge of Automation, GMPs, Compliance, and Regulatory requirements is essentialExcellent communication skills and ability to work in a high-paced team-oriented environment

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.