Validation Area Specialist I

Novo Nordisk AS

Clayton, NC, US
On-site
Perform, review & approve validation/revalidation
Collaborate with it, metrology & stakeholders
Support validation activities for changes
Novo Nordisk is seeking a Validation Area Specialist I for its Clayton, NC facility, where the focus is on producing innovative diabetes and obesity treatments. The role involves managing validation projects and collaborating with various teams to ensure compliance and quality in manufacturing processes

Job Summary

  • Plan, manage & perform low to moderately complex validation projects and activities, supporting engineers with change requests and deviation investigations.
  • Collaborate & coordinate with IT, Metrology & other key stakeholders to ensure quality, cost effectiveness in alignment with budget targets & timely completion of all deliverables.
  • Novo Nordisk offers leading pay, annual performance bonus, generous PTO, comprehensive health insurance, guaranteed 401K contribution, and family-focused benefits.

Matching Summary

Match Score: 85

Novo Nordisk is seeking a Validation Area Specialist I for its Clayton, NC facility, where the focus is on producing innovative diabetes and obesity treatments. The role involves managing validation projects and collaborating with various teams to ensure compliance and quality in manufacturing processes.

Skills & Requirements

Must-have

  • Perform, review & approve validation/revalidation
  • Collaborate with IT, Metrology & stakeholders
  • Support validation activities for changes
  • Root cause analysis for failures
  • cGMP documentation practices & regulations

Nice-to-have

  • Experience with validation test equipment
  • Knowledge of statistical methods
  • Quality concepts including technical review
  • Experience in core validation areas
  • NNWay, Quality & cLEAN® Mindset

Key Requirements

  • Bachelor's Degree + 2 years validation experience
  • Associate's Degree + 4 years validation experience
  • High School Diploma + 6 years validation experience
  • Validation related discipline experience

Work Rights

Not specified

Tailored Resume

Cover Letter