Pharma Validation Specialist I/II

BioSpace

Durham (NC)

On-site

USD 90,000 - 120,000

Full time

3 days ago
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Benefits offered by this job

Leading pay and annual performanceBONu
Paid time off – 14 holidays
Health Insurance from day one
401K with 8% company match
Parental & family medical leave
Tuition Assistance
Life & Disability Insurance
Employee Referral Awards

Job summary

Novo Nordisk in Durham, NC is seeking a Validation Engineer to plan, manage and perform low to moderately complex validation projects. You will support change requests and deviation investigations while collaborating with IT, Metrology, and other stakeholders to ensure quality and cost effectiveness within budget.

The role requires a bachelor’s degree in engineering or related field and 2+ years of validation experience in pharma/medical devices.

Qualifications

  • Bachelor’s degree in engineering, pharmaceutical sciences or related field is required.
  • Minimum two years of validation experience in pharma or medical devices.
  • In lieu of BS, 4 years of related validation experience with an associate’s degree.
  • In lieu of BS with two years, six years of validation experience with a high school diploma.

Responsibilities

  • Perform, review and approve validation/revalidation activities.
  • Review and approve validation documents for accuracy and compliance.
  • Collaborate with cross-functional teams to investigate deviations and implement CAPAs.
  • Support change control and revalidation activities as assigned.
  • Operate in alignment with quality and lean mindset; ensure safety and environment rules.

Skills

Bachelor's degree
2+ years validation experience
Analytical skills
Strong communication
Team collaboration

Education

Bachelor's degree in engineering
Associate's degree in engineering or related field (in lieu)
High school diploma with extensive validation experience (in lieu)

Tools

Microsoft Word
Excel

Job description

Novo Nordisk in Durham, NC is seeking a Validation Engineer to plan, manage and perform low to moderately complex validation projects. You will support change requests and deviation investigations while collaborating with IT, Metrology, and other stakeholders to ensure quality and cost effectiveness within budget.

The role requires a bachelor’s degree in engineering or related field and 2+ years of validation experience in pharma/medical devices.

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