Process Engineer I - Fermentation

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
Ensure successful qualification & execution of the project phases for the Fermentation process, evolving into a process subject matter expert for the Fermentation area. Main tasks include: Support team in ensuring installed design adheres to process requirements. Coordinate & execute process validation activities. Provide technical support of the operating facility to meet business goals. Coach & mentor less experienced members of the process engineering team.
Relationships
Senior Manager, Process Support - API.
Essential Functions

• Overall validation responsible within area
• Execute & coordinate all qualification activities included in the project (SAT, IQ, OQ, PQ)
• Lead / provide technical support to investigation & resolution of VNC's & NC's
• Support development & implementation of change requests during commissioning & operation
• Verify process equipment & facilities satisfy design requirements. Ensure designs comply with current pharmaceutical standards applicable for the project such as ASME BPE, GAMP, cGMP, ISPE guidelines
• Gathering & ensure knowledge transfer to project from DK sponsor site. Support or serve as Process Responsible in Process Groups
• Support work packages in maintaining schedule & project milestone adherence
• Ensure coordination & collaboration between project & other site stakeholders
• Ensure design adheres with process FMECA's & resolve misalignments where observed
• Develop knowledge of risk assessment documents such as requirements risk assessments (RRA's)
• Support update, development & design adherence to requirement specification documents
• Participation in review & update of QRM risk assessments such as closed-system, cross-contamination, contamination & facility flows
• Apply Fermentation knowledge to the review & update of design documentation (process flow diagrams, P&IDs, etc.)
• Provide design basis information for accurate process scheduling & capacity calculations

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 Chemical Engineering, biological / biomedical engineering, or other pharmaceutical related field required
• Minimum of two (2) years of engineering experience in operations, process design/troubleshooting/improvement required
• Six Sigma Green Belt certification or cLEAN® 2-star desired a plus
• Experience of working with cGMPs & their applications preferred
• Demonstrated experience in chemical/biological manufacturing processes a plus
• Knowledgeable in the following systems: Instrument & Electrical, Mechanical, Control/SCADA/PLCs, Process Improvement Methods, Root Cause Analysis (RCA), Maintenance & Reliability a plus
• Ability to independently apply engineering techniques & analysis within the discipline preferred
• Strong project management skills preferred
• Excellent oral & written communication skills preferred
• Proven expertise in planning/organization/execution of maintenance activities & following up on results preferred
• Creating and/or revising the work plan for complex problems being resolved by cross functional teams 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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.