Engineer, Process - Drug Substance

About the DepartmentAt 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 the opportunity to help improve the quality of life for millions of people around the world.Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world. 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 14 weeks paid parental & 6 weeks paid family medical leaveFree access to Novo Nordisk-marketed pharmaceutical productsTuition Assistance Life & 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 PositionThe Engineer, Process - Drug Substance, will support ongoing activities by assisting in troubleshooting mechanical problems, identifying improvements in utilities to minimize interruptions (down time) and reduce energy usage/cost, and supporting new and ongoing projects. This position will further assist in the management and planning of project budgets and schedules and provide contractor oversight.This position will assist in identifying, tracking, forecasting, and implementing capital expenditure projects by working with site leadership and departmental end users to identify the correct project parameters and utility requirements. The Engineer may establish new Standard Operating Procedures (SOPs) and/or recommend changes to current SOPs based on facility needs. This person will work on complex facility-related problems requiring in-depth data analysis to determine appropriate action. The Engineer is expected to have extensive ongoing communication with employees and cross-functional group managers/departments on facility-related issues.RelationshipsReports to Manager or above.Essential FunctionsSupport selection and installation of bioprocessing equipmentProactively and effectively partner with the commissioning/validation team, including operational protocol development, to implement compliance with FDA GMP requirementsDraft SOPs for bioprocess equipment operation, maintenance, and calibrationIdentify improvements and efficiencies of preventative maintenanceProvide engineering guidance and execution on equipment projectsPerform hands-on activities as needed to help troubleshoot equipment problemsEvaluate future capital bioprocess equipment projectsMaintain compliance in accordance with quality management systemGuide the specification and selection of bioprocessing equipment to support process needsDraft, review, execute, and approve protocols and reports related to bioprocess equipment ValidationAct as primary Subject Matter Expert (SME) for bioprocessing equipment Review and approve changes to bioprocessing equipment through the change control program to assess impact on validated systemsAssist in responding to customer/regulatory audit observations and corrective actions as it pertains to bioprocessing equipment Identify and implement improvement opportunities for established production systemsCollaborate significantly with cross functional groups including Validation, Quality Control, Manufacturing, Process Development, and FacilitiesProvide technical assistance and training for personnelFile and maintain controlled documentsComplete knowledge of varied aspects or a single specialized aspect of a discipline and some knowledge of principles and concepts in other disciplinesApply technical and functional knowledge to conduct experiments/research in assigned areaMay act as a technical resource within own work group/project teamWork independently to solve problems of moderate scopeActively participate and suggest solutions to problemsFollow all safety and environmental requirements in the performance of dutiesOther duties as assignedPhysical RequirementsFrequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 30 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities for the position. Working conditions will be heating ventilation and air condition controlled. Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures will be followed to minimize exposure, including clean room gowning. May be exposed to inclement weather or be required to work in environments or under conditions that require the use of protective gear and/or awareness of personal safety and safety of others.QualificationsBachelor's Degree in related field of study from an accredited university required and a minimum of two (2) years of relevant experience required In lieu of Bachelor's Degree with two (2) years of experience, may consider a Master's Degree in related field of study from an accredited university with a minimum of zero (0) year of relevant experience requiredIn lieu of Bachelor's Degree with two (2) years of experience, may consider a PhD/PharmD in related field of study from an accredited university with a minimum of zero (0) year of relevant experience required2+ years of Project Engineering related experienceWe commit to an inclusive recruitment process and equality of opportunity for all our job applicants.At 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.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 View phone number on click.appcast.io. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.