Impact-Driven Pharma Validation Specialist I/II

Novo Nordisk A/S

Durham (NC)

On-site

USD 90,000 - 120,000

Full time

4 days ago
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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

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

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