Validation Area Specialist - OFP

About the Department

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. 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 Emerging Technologies - Oral Finished Products facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. OFP maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

 

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 12 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

Coordinate & drive implementation of science & risk-based validation. The incumbent will provide input to project team members through all stages of specification setting, supplier selection, & commissioning/qualification/verification. Subject matter expert for all NN corporate validation procedures. Perform revalidation on equipment/processes per approved timelines. Support validation activities associated with changes to existing & new systems. The incumbent will set requirements, build/construct, design, commission & perform verification activities for projects according to science & risk-based validation (SRV).

 

Relationships

Assoc Manager, Validation & Process Support – OFP.

 

Essential Functions

• Participate & provide feedback to international corporate validation process group
• Must be ability to work & communicate effectively across multiple local departments & multiple international production sites
• Perform & review system, equipment, utility, & process revalidation per corporate science & risk-based validation principles
• Collaborate, execute, & review IQs, OQs, PQs, & other verification protocols for systems/processes
• Author & review documents in accordance with local, corporate & regulatory regulations
• Support &/or lead the closure of investigations per approved timeframes using root cause analysis & systematic problem-solving techniques
• Participate in teams to help identify root causes of failures & implement corrective actions which address & eliminate potential reoccurrence of the failures
• Lead the development of new processes & product flows
• Understand processes & products at an advanced level
• Support Global OFP sites with investigations & issues, to include on-site support
• Evaluate results of process confirmations of standards for opport