Validation Area Specialist - AP - W&S/Form/Inspec

About the Department

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At PS AM, you’ll join a global network of manufacturing professionals who are passionate about what they do.

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

Perform revalidation on equipment/processes per approved timelines. Support validation activities associated with changes to existing & new systems. Processes include formulation, sterilization, cleaning, filling & inspection.

Relationships

Manager, Technical Support AP.

Essential Functions

• Perform & review revalidation. Must be able to work & communicate effectively across multiple departments to schedule & perform revalidations
• Author and review documents in accordance with local, corporate & regulatory regulations
• Collaborate and review IQ, OQ & PQ protocols for systems/processes per approved timeframes
• Support and/or lead the closure of investigations per approved timeframes using root cause analysis techniques. Participate in teams to help identify root causes of failures & implement corrective actions which address & eliminate potential reoccurrence of the failures
• Participate in continuous improvement initiatives using cLEAN tools and methodology
• Ensure executed protocol data reviewed is accurate & meets documented acceptance criteria
• Responsible for Change Requests (CR’s) related to revalidation & other validation activities for AP
• Author and review validation procedures, specifications & quality documents for accuracy & compliance
• Presentation & support for validation concepts & approaches with audits & inspections
• Follow all safety & environmental requirements in the performance of duties
• Operate in alignment with NNWay, demonstrating a Quality & cLEAN® Mindset
• 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, Computer Science, or applicable scientific or technical degree required
• Minimum of two (2) years of validation related discipline experience in pharmaceutical or medical device industry required
• Experience in quality concepts including technical & compliance review of validation & quality documents preferred
• Experience in one or more core validation areas (sterilization, cleaning, process or computer validation) preferred
• Experience in cGMP documentation practices & regulations preferred
• Basic computer skills including experience in the use of Microsoft word, Excel, etc. preferred
• Knowledge of statistical methods preferred
• Strong oral & written communication skills preferred
• Experience with validation test equipment including temperature mapping equipment (for example: Kaye Validator) preferred
• Experience in project team collaboration & support preferred
• At least one (1) year of demonstrated experience using root-cause analysis techniques to solve problems preferred
• Demonstrated expertise in planning/organizing, managing execution, checking results & revising the work plan for complex problems being resolved by cross functional teams a plus

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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.