Associate Process Engineer API at Novo Nordisk

About the DepartmentAt 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 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 825000 square-feet of state-of-the-art equipment and houses the Fermentation Recovery and Purification in the production of ingredients for Novo Nordisks innovative oral products. At API youll 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 14weeks paid parental & 6 weeks paid family medical leaveFree access to Novo Nordisk-marketed pharmaceutical productsTuition AssistanceLife & Disability InsuranceEmployee Referral AwardsAt 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 PositionProvide routine support & troubleshooting for the manufacturing facility. Primary tasks: Provide input review & approve design & requirement documents; provide input review & approve technical specifications.RelationshipsReports to Manager or Senior Manager.Essential FunctionsSupport development of design & requirement specifications documentsSupport quality of equipment & processesSupport the creation of process tracks risk assessment documents such as Requirement Risk Assessments (RRAs)Participation in the creation of a project cGMP StatementCreate & participate in Quality Risk Management (QRM) risk assessments such as Closed-Process Cross-Contamination Contamination & Facility flowsOwn self development and partner with manager for clear understanding of development needs for desired career pathInput & review to Process FMECAs for the Process tracksParticipation in design work shops with engineering suppliersInput & review of Process Module Diagrams & Process Flow DiagramsInput & review of Process Scheduling & Capacity CalculationsSupport package in maintaining schedule adherenceEnsure coordination & collaboration between project & other site stakeholdersGather & ensure knowledge transfer to project from DK sponsor siteFollow all safety & environmental requirements in the performance of dutiesOther duties as assignedPhysical RequirementsMoves 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.QualificationsBachelors Degree in Engineering Science or relevant technical field of study from an accredited university requiredMay consider an Associates Degree in Engineering Science or relevant technical field of study from an accredited university with a minimum of two (2) years of engineering or technical experience required preferably in a GMP regulated environmentMay consider High School Diploma or equivalent with four (4) years of engineering or technical experience required preferably in a GMP regulated environmentA minimum of one (1) year of engineering or technical experience preferred preferably in a GMP regulated environmentExperience with design of requirements documents a plusExperience working in a GMP regulated environment preferredKnowledge about requirements/expectations of regulatory authorities e.g. FDA a plusExperience with Process Control Systems a plusProven ability to establish & maintain networks & facilitate processes that encourage cross organizational knowledge sharing a plusAbility to provide support for a 24/7 operational business requiredWe commit to an inclusive recruitment process and equality of opportunity for all our job applicants.Were not your typical healthcare a modern world of quick fixes we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science make healthcare more accessible and treat prevent and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real lasting change in health.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.Required Experience:IC Key Skills Internship,Coaching,Information Technology Sales,Administration Support,Financial Planning Employment Type : Full Time Experience: years Vacancy: 1