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Sterility Assurance SME (Process Professional II)

Novo Nordisk AS

  • Clayton, NC
  • 7 days ago
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    Skills

    • Adult Learningunmatched
    • Asepsisunmatched
    • Biotech and Pharmaceuticalunmatched
    • Change Controlunmatched
    • Chronic Diseaseunmatched
    • Coachingunmatched
    • Communication Skillsunmatched
    • Continuous Improvementunmatched
    • Control Systemsunmatched
    • Data Managementunmatched
    • Dental Insuranceunmatched
    • Disability Insuranceunmatched
    • Diseaseunmatched
    • Dosage Formsunmatched
    • Drug Manufacturingunmatched
    • Electronics Manufacturingunmatched
    • Health Insuranceunmatched
    • Healthcareunmatched
    • High School Diplomaunmatched
    • Lean Manufacturingunmatched
    • Lean Six Sigmaunmatched
    • Life Insuranceunmatched
    • Manufacturingunmatched
    • Manufacturing Systemsunmatched
    • Mentoringunmatched
    • Needs Assessmentunmatched
    • Operations Processesunmatched
    • Problem Solving Skillsunmatched
    • Process Improvementunmatched
    • Product Marketingunmatched
    • Quality Controlunmatched
    • Quality Managementunmatched
    • Regulationsunmatched
    • Regulatory Requirementsunmatched
    • Root Cause Analysisunmatched
    • SAPunmatched
    • Six Sigma Certificationunmatched
    • Training/Teachingunmatched
    • Tuition Feesunmatched
    • Vision Planunmatched
    • Warehousingunmatched
    • Willing to Travelunmatched
    • Writing Skillsunmatched

    Description

    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

    Support people, equipment and processes for our operations areas to meet business and regulatory requirements. Support training for lower-level peers. Demonstrate subject matter expertise in assigned area. Provide process solutions for moderate to high complexity issues. Serve as a back-up as needed for the Sr Process Professional and as a mentor/coach for junior team members.

    Relationships

    Reports to Manager. The role is responsible for collaborating with stakeholders related to assigned area. Support training for lower-level team members.

    Essential Functions

    • Responsible for providing in depth deviation investigations and root cause analysis
    • Drive continuous improvements via Lean tools and Six Sigma methodologies and certifications
    • Responsible for area content and process knowledge
    • Identify and implement process needs and improvement opportunities for moderate to high complexity issues
    • Responsible for periodic reviews and reporting. Involved with collaboration across sites
    • Update and manage area master data and recipes as needed
    • Provide support on defined issues and contributes through application of expertise and knowledge
    • Follow all safety & environmental requirements in the performance of duties
    • Other duties as assigned

    Physical Requirements

    Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 20% of the time (% can change on a case by case basis based on the role.)

    Qualifications

    • Bachelor's degree (engineering, technology or related field of study preferred) from an accredited university required
    • May consider an Associate's degree (engineering, technology or related field of study preferred ) in technology or related field of study from an accredited university with a minimum of four (4) years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment
    • May consider a High School Diploma (GED) with a minimum of six (6) years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment
    • Minimum of two (2) years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment
    • Excellent written communication skills required
    • Thorough investigation and systematic problem-solving experience required
    • LEAN manufacturing experience and training required
    • General knowledge of change control systems and Quality Management Systems (QMS) required
    • Relevant electronic manufacturing system experience required (ex: SAP, PAS-X, etc.)
    • Demonstrated knowledge of adult learning methodologies and ability to use multiple methods to train and coach others preferred
    • General experience with regulatory audits/inspections required
    • Knowledge of relevant master data preferred
    • Validation experience preferred
    • Product transfer (or tech transfer) experience a plus

    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.

    Numbers & Facts

    LocationClayton, NC
    IndustryBiotechnology/Pharmaceuticals
    Company Size2,500 to 4,999 employees
    Year Founded1923
    Websitehttps://www.novonordisk.com/

    About Company

    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.

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