Position

Validation Area Specialist - AP

Job description

Job description

Location

Clayton, United States

Job category

Quality

About the Department   

At Novo Nordisk, we want to make a difference. For nearly 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 Clayton, NC, we now operate two adjacent pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains.  
 
Our Clayton, NC Diabetes Finished Products (DFP) facility is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. When you work at DFP, you’ll join a global network of manufacturing professionals focused on several key, final production processes, including sterile formulation, filling, inspection, device assembly and packaging. 
 
At DFP, our employees are passionate about what they do, knowing their work makes a difference to millions of people who rely on our products every day. After all, producing medicines is a special responsibility. 
 
Join Team Novo Nordisk and help us make what matters.

 

Position Purpose

Perform Revalidation & Periodic System Evaluations (PSE) on equipment/processes per approved timelines. Support validation activities associated with changes to existing & new systems. Processes include formulation, sterilization, cleaning, filling & inspection.

 

Accountabilities

  • Perform, review & approve revalidation & PSE activities. Must be able to work & communicate effectively across multiple departments to schedule & perform revalidation & PSE assignments
  • Review & approve documents in accordance with local, corporate & regulatory regulations
  • Collaborate, review & approve 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
  • 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
  • Review & approve 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

 

Required Education

BS in Engineering, Computer Science, or applicable scientific or technical degree.

 

Required Experience

2+ years validation related discipline experience in pharmaceutical or medical device industry.

 

Technical/Process/Functional Knowledge

  • Experience in quality concepts including technical & compliance review of validation & quality documents
  • Experience in one or more core validation areas (sterilization, cleaning, process or computer validation)
  • Experience in cGMP documentation practices & regulations
  • Basic computer skills including experience in the use of Microsoft word, Excel, etc.
  • Knowledge of statistical methods
  • Strong oral & written communication skills
  • Experience with validation test equipment including temperature mapping equipment (for example: Kaye Validator), desired
  • Experience in project team collaboration & support
  • At least 1 year of demonstrated experience using root-cause analysis techniques to solve problems

 

Organization/Planning

Demonstrated expertise in planning/organizing, managing execution, checking results & revising the work plan for complex problems being resolved by cross functional teams.

 

Physical Requirements

  • Occasionally moves equipment and/or supplies weighing up to 33 pounds within the facility using various body positions
  • Constantly operates a computer & other office equipment using hands
  • Able to work in an open office environment with the possibility of frequent distraction
  • Able to work the hours necessary to support a 24/7 continuous manufacturing operation
  • Able to adjust schedule to work with colleagues in other international time zones

 

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.