{"schemaVersion":"jobsearcher.job.v1","id":"3cd3f560853f8593591339e9","url":"https://jobsearcher.com/jobs/3cd3f560853f8593591339e9","canonicalUrl":"https://jobsearcher.com/jobs/3cd3f560853f8593591339e9","title":"Associate Process Engineer - API","description":"About the Department\nAt 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.\n\nIn 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.\n\nWhat we offer you\n\nLeading pay and annual performance bonus for all positions\n\nAll employees enjoy generous paid time off including 14 paid holidays\n\nHealth Insurance, Dental Insurance, Vision Insurance - effective day one\n\nGuaranteed 8% 401K contribution plus individual company match option\n\nFamily Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave\n\nFree access to Novo Nordisk‑marketed pharmaceutical products\n\nTuition Assistance\n\nLife & Disability Insurance\n\nEmployee Referral Awards\n\nThe Position\nProvide routine support & troubleshooting for the manufacturing facility. Primary tasks: provide input, review & approve design & requirement documents; provide input, review & approve technical specifications.\n\nRelationships\nReports to Manager or Senior Manager.\n\nEssential Functions\n\nSupport development of design & requirement specifications documents\n\nSupport quality of equipment & processes\n\nSupport the creation of process tracks risk assessment documents, such as Requirement Risk Assessments (RRA's)\n\nParticipation in the creation of a project cGMP Statement\n\nCreate & participate in Quality Risk Management (QRM) risk assessments, such as Closed-Process, Cross-Contamination, Contamination & Facility flows\n\nOwn self development and partner with manager for clear understanding of development needs for desired career path\n\nInput & review to Process FMECA's for the Process tracks\n\nParticipation in design workshops with engineering suppliers\n\nInput & review of Process Module Diagrams, & Process Flow Diagrams\n\nInput & review of Process Scheduling & Capacity Calculations\n\nSupport package in maintaining schedule adherence\n\nEnsure coordination & collaboration between project & other site stakeholders\n\nGather & ensure knowledge transfer to project from DK sponsor site\n\nFollow all safety & environmental requirements in the performance of duties\n\nOther duties as assigned\n\nPhysical Requirements\nMoves 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.\n\nQualifications\n\nBachelor's Degree in Engineering, Science, or relevant technical field of study from an accredited university required\n\nBachelor's degree in engineering/related field or anticipated Bachelor's degree in engineering/related field by 6/30/26 required, or within 12 months of application required.\n\nMay consider an Associate's 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 environment\n\nMay consider High School Diploma or equivalent with four (4) years of engineering or technical experience required, preferably in a GMP regulated environment\n\nA minimum of one (1) year of engineering or technical experience preferred, preferably in a GMP regulated environment\n\nExperience with design of requirements documents a plus\n\nExperience working in a GMP regulated environment preferred\n\nKnowledge about requirements/expectations of regulatory authorities e.g. FDA a plus\n\nExperience with Process Control Systems a plus\n\nProven ability to establish & maintain networks & facilitate processes that encourage cross organizational knowledge sharing a plus\n\nAbility to provide support for a 24/7 operational business required\n\nWe commit to an inclusive recruitment process and equality of opportunity for all our job applicants.\n\nAt Novo Nordisk, we're not chasing quick fixes - we're creating lasting change for long‑term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger - a legacy of impact that reaches far beyond today.\n\nNovo 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.\n\nIf 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.\n\n#J-18808-Ljbffr","company":"Merck","rawCompany":"merck","city":"Clayton","state":"NC","isRemote":false,"isActive":false,"createdAt":"2026-06-17T03:38:12.008Z","occupations":[{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2041.00","title":"Chemical Engineers","slug":"chemical-engineers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Associate Process Engineer - API","description":"About the Department\nAt 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.\n\nIn 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.\n\nWhat we offer you\n\nLeading pay and annual performance bonus for all positions\n\nAll employees enjoy generous paid time off including 14 paid holidays\n\nHealth Insurance, Dental Insurance, Vision Insurance - effective day one\n\nGuaranteed 8% 401K contribution plus individual company match option\n\nFamily Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave\n\nFree access to Novo Nordisk‑marketed pharmaceutical products\n\nTuition Assistance\n\nLife & Disability Insurance\n\nEmployee Referral Awards\n\nThe Position\nProvide routine support & troubleshooting for the manufacturing facility. Primary tasks: provide input, review & approve design & requirement documents; provide input, review & approve technical specifications.\n\nRelationships\nReports to Manager or Senior Manager.\n\nEssential Functions\n\nSupport development of design & requirement specifications documents\n\nSupport quality of equipment & processes\n\nSupport the creation of process tracks risk assessment documents, such as Requirement Risk Assessments (RRA's)\n\nParticipation in the creation of a project cGMP Statement\n\nCreate & participate in Quality Risk Management (QRM) risk assessments, such as Closed-Process, Cross-Contamination, Contamination & Facility flows\n\nOwn self development and partner with manager for clear understanding of development needs for desired career path\n\nInput & review to Process FMECA's for the Process tracks\n\nParticipation in design workshops with engineering suppliers\n\nInput & review of Process Module Diagrams, & Process Flow Diagrams\n\nInput & review of Process Scheduling & Capacity Calculations\n\nSupport package in maintaining schedule adherence\n\nEnsure coordination & collaboration between project & other site stakeholders\n\nGather & ensure knowledge transfer to project from DK sponsor site\n\nFollow all safety & environmental requirements in the performance of duties\n\nOther duties as assigned\n\nPhysical Requirements\nMoves 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.\n\nQualifications\n\nBachelor's Degree in Engineering, Science, or relevant technical field of study from an accredited university required\n\nBachelor's degree in engineering/related field or anticipated Bachelor's degree in engineering/related field by 6/30/26 required, or within 12 months of application required.\n\nMay consider an Associate's 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 environment\n\nMay consider High School Diploma or equivalent with four (4) years of engineering or technical experience required, preferably in a GMP regulated environment\n\nA minimum of one (1) year of engineering or technical experience preferred, preferably in a GMP regulated environment\n\nExperience with design of requirements documents a plus\n\nExperience working in a GMP regulated environment preferred\n\nKnowledge about requirements/expectations of regulatory authorities e.g. FDA a plus\n\nExperience with Process Control Systems a plus\n\nProven ability to establish & maintain networks & facilitate processes that encourage cross organizational knowledge sharing a plus\n\nAbility to provide support for a 24/7 operational business required\n\nWe commit to an inclusive recruitment process and equality of opportunity for all our job applicants.\n\nAt Novo Nordisk, we're not chasing quick fixes - we're creating lasting change for long‑term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger - a legacy of impact that reaches far beyond today.\n\nNovo 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.\n\nIf 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.\n\n#J-18808-Ljbffr","datePosted":"2026-06-17T03:38:12.008Z","dateModified":"2026-06-17T03:38:12.008Z","hiringOrganization":{"@type":"Organization","name":"Merck","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Clayton","addressRegion":"NC","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"3cd3f560853f8593591339e9"},"url":"https://jobsearcher.com/jobs/3cd3f560853f8593591339e9"}}