Project Validation Specialist Lead - Site C

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 legacy Injectable Finished Products (IFP) 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 IFP, 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 12 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance – reimbursement up to $10,000 annually 
• 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.
 

Position Purpose

Validation Lead (Project Quality) for IFP expansion projects. Provides comprehensive validation subject matter expertise (i.e., equipment, facility, cleaning, sterilization, product, process validation). Builds detailed knowledge of the Novo Nordisk validation procedures/validation manual & directs project areas in developing compliant validation strategies.

Accountabilities

• Build Subject Matter Expert (SME) understanding of the Novo Nordisk science & risk-based validation procedures
• Provide SME level knowledge to project groups
• Leads the development of all electronic validation structure
• Identify & implement lean project execution activities
• Translate procedural requirements within the validation area into practical workflows guiding the project execution
• Identify & implement improvements that support lean project execution
• Build strong cross-functional relations with Novo Nordisk project organization & validation project contributors (local & abroad)
• Other accountabilities, as assigned

Required Qualifications

BA/BS degree in pharmaceutical, engineering, or other technical science field or equivalent combination of education & experience.

Desired Qualifications

• MA/MS degree in pharmaceutical, engineering, or other technical science field or equivalent combination of education & experience
• Minimum of eight (8) years of equipment & facilities validation experience
• SME experience from pharma production environment
• Preferred knowledge of Novo Nordisk science & risk-based validation procedures
• Proven experience with quality systems preferably within pharma industry
• Experienced in the development, implementation, validation &/or maintenance of equipment & facilities in the pharmaceutical/medical device manufacturing, laboratory, or business environment
• Project execution experience, preferably in a Novo Nordisk context, as supplier or internal SME
• Understanding of lean project execution principles, continuous improvements & application in a small & large-scale project environment
• Solid project execution experience & the ability to link/translate validation procedures & principles to practical hands-on project work processes
• Experience in working with external engineering consultants & ensuring integration of NN quality requirements
• Familiar with LEAN, & continuous improvement methodologies
• Written & verbal communication skills to allow interaction with all levels of operations & management
• Proven expertise in project management, in planning/organization, &/or project execution
• Follow-up & completion
• SME level skills within validation & the links to project execution planning

Physical & Other Requirements

• Occasionally moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions
• Occasionally operates & inspects manufacturing equipment using hands
• Occasionally ascends\descends a ladder to service equipment & can work atop elevated positions
• Occasionally works around odorous &/or hazardous materials.  May be required to wear latex gloves
• Occasionally performs critical job functions in extremely cold work environments
• Occasionally positions oneself within confined spaces for inspection, repair & maintenance of equipment
• Ability to work in loud noise environments with hearing protection
• Occasionally works in outdoor weather conditions
• Ability to work in an open office environment with the possibility of frequent distraction
• Ability to work the hours necessary to support a 24/7 continuous manufacturing operation
• Ability to travel locally & internationally as necessary
• Ability to work flexible hours to support international delivery team

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.