Process Engineer (Level I-III) - Biotech Manufacturing

Novo Nordisk AS

West Lebanon, NH

JOB DETAILS
SKILLS
Application Programming Interface (API), Automation, Biology, Biotech and Pharmaceutical, Cell Cultures, Chronic Disease, Communication Skills, Corrective Action, Cross-Functional, Current Good Manufacturing Practice (cGMP), Disease, Documentation, Environmental Sciences, Equipment Maintenance/Repair, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), Healthcare, Hemophilia, Identify Issues, Instrumentation, Manufacturing, Manufacturing/Industrial Processes, Material Audit, Medications, Mentoring, On Call, Operations Management, Presentation/Verbal Skills, Preventative Maintenance, Procedure Development, Procedure Implementation, Process Development, Process Engineering, Process Improvement, Product Marketing, Production Support, Regulations, Requirements Validation/Verification, Risk, Root Cause Analysis, Standard Operating Procedures (SOP), Support Documentation, System Start-Up, Team Player, Technical Support, Time Management, Trend Analysis, Willing to Travel, Writing Skills
LOCATION
West Lebanon, NH
POSTED
27 days ago

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 upstrem cell culture 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 maintenance 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: Sr. Manager, Process Support

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%.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, were not chasing quick fixes - were creating lasting change for long-term health. For over 100 years, weve 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 whats possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, were 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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

About the Company

N

Novo Nordisk AS

Working at Novo Nordisk

 

Life-changing careers

Starting a career at Novo Nordisk is more than getting a job. It is an opportunity to improve the lives of millions of people living with a serious chronic disease.

Whether you are a part of supplying insulin for patients around the world, discovering the next breakthrough at one of our state-of-the-art research centres, working with us is truly life-changing.

 

We are inspired by life

We are a proud life-science company on a mission to ensure that people living with a chronic disease can live a full life. Millions rely on us.

We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. From our colleagues in the lab, working to change lives through pioneering break-through treatments, to our colleagues putting sustainability at the core of our processes and working to prolong the life of our planet, this mission to improve lives is at the core of our every action.

 

Together we drive change

Change is a constant — change in lifestyle, change in technology, change all over. At Novo Nordisk, we don’t wait for change. We drive it.

We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future.

That’s why we continuously push to improve the way we work and the lives of the patients we serve, creating innovative solutions that fit the way people want to live. To accomplish this, we embrace a spirit of open-mindedness and experimentation, striving for excellence without fixating on perfection.

 

Together, we are life-changing

Our company is our people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We want to ensure that every employee can achieve a work-life balance that supports their current priorities and where they want to go next.

 

Your development starts here

We value our employees for the unique skills, backgrounds and perspectives they bring to the table. We work continuously to help bring out the best in all of our people, offering opportunities for development and creating an environment of mobility within the company. We strive to offer a workplace that’s great to be in and to be from.

It is very important to us that anyone working with us feels empowered as an employee and as a person. We all should have the opportunity to act fast, make decisions and be agile. 

With a career at our company, you will feel a difference right from the start. A sense of inspiration that comes from a shared belief in driving positive change for people, families and communities everywhere, and it’s a collective effort. We rely on the joint potential and collaboration of our more than 45,000 employees.

In the video above, meet  Marie Darting, one of our scientists, and hear more about her work as a formulation scientist, her perspective on development plans and the impact she feels her work has on people living with a chronic disease.

 

Who we are

We were founded in 1923 and today we are a global healthcare company headquartered just outside Copenhagen, 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 diabetes.

With almost 100 years of experience, one of the broadest diabetes product portfolios in the healthcare industry, as well as an award-winning pipeline of innovative products, our success is built on our company values – the Novo Nordisk Way.

COMPANY SIZE
2,500 to 4,999 employees
INDUSTRY
Biotechnology/Pharmaceuticals
FOUNDED
1923
WEBSITE
https://www.novonordisk.com/