Validation Area Specialist I​/II - SDF

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 the opportunity to help improve the quality of life for millions of people around the  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
-Solid Dosage Forms US 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. SDF 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 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 Plan, manage & perform low to moderately complex validation projects and activities. Support engineers with writing change requests and conducting/writing deviation investigations. Support validation activities associated with changes to existing & new systems as assigned. Process equipment supported includes propagation, fermenters, media sterilizers and the related supporting equipment. Collaborate & coordinate with IT, Metrology & other key stakeholders to ensure quality, cost effectiveness in alignment with budget targets & timely completion of all deliverables.

Relationships Reports to Manager, Director.

Essential Functions Perform, review & approve validation/revalidation. Must be able to work & communicate effectively across multiple departments to schedule & perform validation/revalidation assignments

Review & approve documents in accordance with local, corporate & regulatory regulations

Collaborate, review & approve protocols for systems/processes per approved time frames

Participate in teams to help identify root causes of failures & implement corrective actions which address & eliminate potential reoccurrence of the failures, to include supporting investigation closure per approved time frames using root cause analysis techniques

Ensure executed protocol data reviewed is accurate & meets documented acceptance criteria

Responsible for Change Requests (CR’s) related to revalidation & other validation activities as assigned

Review & approve validation procedures, specifications & quality documents for accuracy & compliance

Provide support for validation concepts & approaches with audits & inspections as assigned

Support change control process and identify opportunities for improvements

Author & review validation procedures, specifications & quality documents for accuracy & compliance

Operate in alignment with NNWay, demonstrating a Quality & cLEAN Mindset 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 10% of the time. (% can change on a case-by-case basis based…