Technical Specialist - Engineering Systems

Novo Nordisk AS

Clayton, NC

JOB DETAILS
SKILLS
Asepsis, Biology, Biotech and Pharmaceutical, Budget Management, Business Strategy, CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), Chronic Disease, Code of Federal Regulations, Communication Skills, Computer Skills, Continuous Improvement, Current Good Manufacturing Practice (cGMP), Customer Support/Service, Database Management Software/Systems (DBMS), Dental Insurance, Disability Insurance, Disease, Documentation Standards, Dosage Forms, Electronic Engineering, Engineering Management, Environmental Regulations, Equipment Validation, GxP, Health Insurance, Healthcare, High School Diploma, Information Systems/Technology IS/IT Administration, Internet Technology, Interoperability, Lean Six Sigma, Life Insurance, Manufacturing, Mentoring, Microsoft Access Database, Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word, People Management, Problem Solving Skills, Process Improvement, Product Documentation, Product Marketing, Project Execution, Quality Assurance, Quality Control, Quality Management, Regulations, Risk Management, SAP, Safety Training, Standard Operating Procedures (SOP), Strategic Planning, System Integration (SI), Systems Administration/Management, Technical Presentation, Technical Strategy, Tuition Fees, Vision Plan, Warehousing, Willing to Travel, Writing Skills
LOCATION
Clayton, NC
POSTED
3 days ago

About the Department

You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk's 50,000 employees.

FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world.

What we offer you:

  • Leading pay and annual performance bonus for all positions
  • All employees enjoy generous paid time off including 14 paid holidays
  • Health Insurance, Dental Insurance, Vision Insurance - effective day one
  • Guaranteed 8% 401K contribution plus individual company match option
  • Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
  • Free access to Novo Nordisk-marketed pharmaceutical products
  • Tuition Assistance
  • Life & Disability Insurance
  • Employee Referral Awards

At 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 Position

Serve as Subject Matter Expert (SME) and provide administrator-level knowledge of various electronic engineering systems including EDMS, BIM, Procore, EIDA, ACC, etc. from a functional perspective. The position is the liaison between other internal stake holders such as the FFEx core team, QA, IT and external contractors where necessary to facilitate engineering systems control. The strategic direction and technical expertise provided by this role will drive project success and foster a culture of innovation and continuous improvement.

Relationships

Reports to Senior Manager/Director

Essential Functions

  • Provide technical expertise to the engineering team as it relates to electronic engineering systems
  • Lead and provide guidance to evaluate, implement, and validate a robust EDMS capable of handling a variety of document types
  • Serve as the technical expert related to electronic engineering systems projects
  • Define and support the achievement of department goals according to company objectives and strategies
  • Propose, guide, and evaluate solutions for process/maintenance changes and continuous process improvements
  • Implement new technologies for the process/maintenance, planning and coordinating of changes according to applicable regulatory procedures
  • Identify and mitigate potential risks and challenges in projects
  • Facilitate problem solving, investigations, and process improvements
  • Collaborate with internal stakeholders to integrate Engineering Systems with other and existing systems. Ensure seamless data flow and optimize system interoperability
  • Create governance structure including procedures for Engineering Systems
  • Responsible for system administration, system upgrades and enhancements, user support, and continuous improvement
  • Present as the technical expert for assigned processes to auditors/inspectors regarding complex subject matter
  • Assist in preparing and managing engineering budgets
  • Follow all safety and environmental requirements in the performance of duties
  • Other accountabilities, as assigned

Physical Requirements

Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time (% can change on a case-by-case basis based on the role)

Qualifications

  • Bachelor's degree in engineering or related field of study from an accredited university required

  • May consider an associate's degree in engineering technology or related field of study from an accredited university with a minimum of ten (10) of manufacturing experience required, preferably in a pharmaceutical or life sciences industry

  • May consider a High School Degree or equivalent with a minimum of twelve (12) years of manufacturing experience required, preferably in a pharmaceutical or life sciences industry

  • Minimum of eight (8) years of manufacturing experience required, preferably in a pharmaceutical or life sciences industry

  • Ability to read, write and understand complicated product documentation and standard operating procedures with attention to high-level concepts required

  • Ability to drive continuous improvements via Lean tools and Six Sigma methodologies required

  • Excellent written communication skills, investigative writing, and computer skills (MS Word, Outlook, Excel, PowerPoint, Access, SAP) required

  • Strong technical knowledge of Engineering Systems including EDMS, BIM, CAD, COMOS, Procore, EIDA, Aconex, etc. required

  • Proficiency in web technologies, database management, and systems integration preferred

  • Demonstrated ability to shape and execute a strategy in a complex international environment preferred

  • Solid understanding of cGMP's and 21 CFR Part 11 requirements, quality management including principles for validation of equipment, utilities, and facilities required

  • Recent project execution experience, successfully led large and complex global GxP investments projects required

  • Up to date knowledge of industry trends, best practices, and regulatory requirements related to Engineering Systems required

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/