Process Engineer I

5 days ago

Lebanon, Oregon, United States Novo Nordisk Full time

About the Department

Site New Hampshire, located in West Lebanon, is where Novo Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications.

What we offer you:

Leading pay and annual performance bonus for all positions36 Paid days off including vacation, sick days & company holidaysHealth Insurance, Dental Insurance, Vision InsuranceGuaranteed 8% 401K contribution plus individual company match option12 weeks Paid Parental LeaveFree access to Novo Nordisk-marketed pharmaceutical products At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?
The Position Responsible for assisting with design and implementation of manufacturing processes, instrumentation and equipment start-ups from the laboratory through manufacturing scale. Relationships According to the organizational chart Number of subordinates with direct/indirect referral: n/a Essential FunctionsAssist with coordinating fabrication, procurement, installation, engineering start-up, verification and validation activities of new equipment and systems. Responsibilities include verification protocol execution (FAT, SAT, DQ, Commissioning, IQ, OQ, & PQ), data analysis and final report preparationParticipate 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 verificationSupport person for process improvement activities; including performing or authoring equipment specifications, user and functional requirements specifications, and necessary FAT and SAT protocolsMaintain effective communication and ensure alignment in coordination with appropriate teamsSupport facility certification for new Manufacturing (process equipment & facility-support equipment) and Quality Control facilities as needed as well as the continued operation of such facilitiesEnsures systems and processes are verified and validated in a compliant manner in accordance with FDA, EU and NN requirementsActively participate on cross functional teams to determine the root cause and corrective actions for problems associated with investigationsCompletes accurate and timely assessments associated with change control activitiesEnsures change control activities for systems are completed in a manner in compliance with FDA, EU and NN regulationsResponsible for the verification of new and existing equipment, processes and instrumentation as neededWrite and review protocols, summary reports and other documentation associated with verification, and validationsCoordinate scheduling of verification activities within Novo Nordisk US Bio Production, Inc. as well as with outside vendors as neededRepresent the Manufacturing Engineering department on cross-functional teams (Manufacturing, Engineering, Technical Support and Quality groups)Performs 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 others Physical Requirements 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. Local and International Travel: 0-10%. QualificationsEducation and Certifications:Requires a Bachelor's degree in engineering or related disciplineWork Experience:A minimum of two (2) years related experience. Prefer medium to large scale pharmaceutical or biotechnology process experienceKnowledge, Skills, and Abilities:Ability to follow routine work instructions for new and ongoing projects and assignmentsKnowledge of Automation and GMPs requirements preferredBroad understanding of science and risk-based verification (I.E. ASTM E2500)Knowledge of good engineering practicesExcellent written and verbal communication skills a mustExcellent communication skills and ability to work in a high-paced team-oriented environmentAbility to provide evening, nighttime, and weekend on call support as neededTechnical requirements for Validation and of biopharmaceutical equipment, facilities and/or instrumentation 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 This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

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