Process Engineer Level I-II (Downstream)

Job Details
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 positions 36 Paid days off including vacation, sick days & company holidays Health Insurance, Dental Insurance, Vision Insurance Guaranteed 8% 401K contribution plus individual company match option 14 weeks Paid Parental Leave Free 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
This role will be part of our bioproduction downstream purification process support team, dedicated to one of our manufacturing suites. Responsible for supporting production through on-floor knowledge and support, documentation to keep production running efficiently, supporting training of technicians to run according to cGMP requirements, ensuring routine preventative mainteanance and equipment repairs are carried out correctly. May be responsible for assisting with design and implementation of manufacturing processes, instrumentation and equipment start-ups from the laboratory through manufacturing scale. The Process Engineer will work alongside Process Associates and Process Scientists and may support day to day issues in manufacturing such as: deviation investigations, CAPAs, equipment troubleshooting, small scale process development, SOP review, escalating complex issues to appropriate stakeholders, or participating in process confirmations on the shop floor. This role will work cross functionally with groups/departments across our site to ensure operational efficiencies and successful production of API onsite. This role will require entering our sterile cleanroom areas while following all relevant gowning, safety, and quality policies. Prior experience in a GMP environment or life science industry is a plus for this role.
The job level and title of hired candidate will be commensurate with experience. This is an onsite based position Monday-Friday at our bioproduction facility in West Lebanon, NH.
Relationships
Reports to: Manager, Process Support (Downstream)
Essential Functions

Assist with SOPs, JIs, DVs and other production documentation to the shopfloor Participate in the development and implementation of procedural or automation improvement changes Participate in production-driven improvements to the process and equipment on shopfloor. Drive an own minor improvement initiatives and support colleagues Develop, write and support any documentation needed in the production as well as supporting trend reports and complex cases owned by the area. Presents this during audits/inspections Maintain effective communication and ensure alignment in coordination with appropriate teams Plan and execute according to timeline and in a compliant manner and ensure timely deliveries of own activities Ensures systems and processes are verified and are kept in a validated state in accordance with FDA, EU and NN requirements Actively participate in cross functional teams to determine the root cause and corrective actions for problems associated with investigations Write and review protocols, summary and trend reports and other documentation associated with ongoing production, verification, and validations Coordinate scheduling of improvement and critical production activities within own area, across areas and as well as with outside vendors as needed Represent the Manufacturing department in cross-functional teams (Manufacturing, Engineering, Technical Support and Quality groups) and present relevant material during audits/inspections Participate in on-call rotations, including weekends and non-business hours, to provide support Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others Other duties as assigned

Qualifications

Education and Certifications:Bachelor's degree in engineering or related discipline required

Work Experience:Bachelor's degree with three (3) years related experience required Medium to large scale pharmaceutical or biotechnology process experience preferred

Knowledge, Skills, and Abilities:Ability to follow routine work instructions for new and ongoing projects and assignments Knowledge of Automation and GMPs requirements preferred Broad understanding of science and risk-based verification (I.E. ASTM E2500) Knowledge of good engineering practices Excellent written and verbal communication skills a must Excellent communication skills and ability to work in a high-paced team-oriented environment Ability to provide evening, nighttime, and weekend on call support as needed Technical requirements for Validation and of biopharmaceutical equipment, facilities and/or instrumentation preferred Employee must remain accessible during on-call period and must be able to provide support/respond within sixty (60) minutes

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%.
Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
We're not your typical healthcare company. In 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 . This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
Company
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk.com .
Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R&D, from early research through late-stage clinical development. We are building for the future by creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients.
CONNECT
Company info
Website Phone Location 75 Hayden Avenue
Lexington
MA
02421
United States
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