Validation Area Specialist I/II - SDF

Novo Nordisk A/S; Durham (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health Insurance

Paid holidays

401K match

Tuition Assistance

Life & Disability Insurance

Job summary

Novo Nordisk A/S in Durham, NC seeks a Validation professional to plan, manage and perform low to moderately complex validation projects. You will support change requests, write deviation investigations, and collaborate with IT, Metrology and other stakeholders to ensure timely, compliant deliverables.

The role requires a BS in engineering (or equivalent) with 2+ years in pharma/medical device validation, strong documentation skills, and experience with validation areas such as equipment and

Qualifications

• BS in engineering or related field required with validation experience in pharma/medical devices
• Experience in cGMP document practices and regulations preferred
• Ability to work cross-functionally and manage multiple validation activities

Responsibilities

• Plan, perform, review and approve validation/revalidation.
• Review documents per regulatory requirements.
• Coordinate with IT, Metrology and other stakeholders.
• Identify root causes of failures and drive corrective actions.
• Support change control and validation change requests.
• Ensure protocol data meet acceptance criteria.

Skills

Validation

Documentation

Root Cause Analysis

Cross-functional

Education

Bachelor’s degree in engineering

Associate’s degree +4 yrs validation exp

High School Diploma +6 yrs validation exp

Tools

Ellab Validator

Microsoft Word

Excel

Quality systems

Job description

Select how often (in days) to receive an alert: Create Alert

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 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 14weeks 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 timeframes
• 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 timeframes 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 on the role.).

Minimum Qualifications

• Bachelor’s degree in engineering, pharmaceutical sciences or related field of study from an accredited university required and a minimum of two (2) years of validation related discipline experience in pharmaceutical or medical device industry required
• In lieu of BS degree + two (2) years of experience, may consider an Associate’s Degree in engineering, pharmaceutical sciences or related field of study from an accredited college or university required with a minimum of four (4) years of relevant validation experience in pharmaceutical or medical device industry required
• In lieu of BS degree with two (2) years of experience, may consider a High School Diploma or equivalent required with a minimum of six (6) years of relevant validation experience in pharmaceutical or medical device industry required

Preferred Qualifications

• Experience in quality concepts including technical & compliance review of validation & quality documents preferred
• Experience in one or more core validation areas (equipment, sterilization, cleaning, process clean & black utilities or computer validation) preferred
• Experience in cGMP documentation practices & regulations preferred
• Basic computer skills including experience in the use of Microsoft word, Excel, etc preferred
• Knowledge of statistical methods preferred
• Experience with validation test equipment including temperature mapping equipment (for example: Ellab Validator), desired preferred
• Experience working with cross functional teams preferred
• Beginning knowledge of problem-solving using root-cause analysis techniques to solve problems preferred
• Demonstrated expertise in planning/organizing, managing execution, checking results & revising the work plan for complex problems being resolved by cross functional teams a plus

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

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.