Validation Area Specialist

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 -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

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

Manager, 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 opportunities to leverage & share ideas for improvements site/division/company wide
• Track & assess effectiveness of corrective / preventative actions from audits, inspections & investigations
• Participate in continuous improvement initiatives using cLEAN tools & 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 & review validation procedures, specifications & quality documents for accuracy & compliance
• Present & support validation concepts & approaches for audits & inspections
• Follow all safety & environmental requirements in the performance of duties
• Operate in alignment with NNWay, demonstrating a Quality & cLEAN® Mindset
• Provide oversight & administration for the training program
• 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 or related technical field or equivalent combination of education & experience required
• Minimum of five (5) 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 required
• Experience in one or more core validation areas (equipment, cleaning, process, or computer validation) preferred
• Experience in cGMP documentation practices & regulations required
• Basic computer skills including experience in the use of Microsoft Word, Excel, etc. required
• Strong oral & written communication skills required
• Experience with validation test equipment including temperature mapping equipment 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
• Organization/Planning: Demonstrated expertise in planning/organizing, managing execution, checking results & revising the work plan for complex problems being resolved by cross functional teams preferred

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.