What are the responsibilities and job description for the Project Quality Assurance Validation Lead - Site Capacity position at Novo Nordisk?
About The Department
You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk’s 50,000 employees.
FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world.
What We Offer You
The Position
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.
Relationships
Reports to Senior Project Manager, Site Capacity & Upfit.
Essential Functions
May move equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. May be required to be on your feet for up to a 12-hour shift. May required corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. May require the ability to work in loud noise environments with hearing protections.
Qualifications
At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.
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.
You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk’s 50,000 employees.
FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world.
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
The Position
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.
Relationships
Reports to Senior Project Manager, Site Capacity & Upfit.
Essential Functions
- 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
May move equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. May be required to be on your feet for up to a 12-hour shift. May required corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. May require the ability to work in loud noise environments with hearing protections.
Qualifications
- Bachelor's Degree in pharmaceutical, engineering, or other technical science field or equivalent combination of education & experience required
- MA/MS degree in pharmaceutical, engineering, or other technical science field or equivalent combination of education & experience preferred
- Minimum of eight (8) years of equipment & facilities validation experience preferred
- SME experience from pharma production environment preferred
- Preferred knowledge of Novo Nordisk science & risk-based validation procedures preferred
- Proven experience with quality systems preferably within pharma industry preferred
- Experienced in the development, implementation, validation &/or maintenance of equipment & facilities in the pharmaceutical/medical device manufacturing, laboratory, or business environment preferred
- Project execution experience, preferably in a Novo Nordisk context, as supplier or internal SME preferred
- Understanding of lean project execution principles, continuous improvements & application in a small & large-scale project environment preferred
- Solid project execution experience & the ability to link/translate validation procedures & principles to practical hands-on project work processes preferred
- Experience in working with external engineering consultants & ensuring integration of NN quality requirements preferred
- Familiar with LEAN, & continuous improvement methodologies preferred
- Written & verbal communication skills to allow interaction with all levels of operations & management preferred
- Proven expertise in project management, in planning/organization, &/or project execution preferred
- Follow-up & completion preferred
- SME level skills within validation & the links to project execution planning preferred
At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.
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.