Validation Specialist I/II - Equipment & Systems

BioSpace; Durham (NC); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

Leading pay and annual bonus

Paid time off including holidays

Health Insurance, Dental Insurance, V

401K matching option

Parental & family leave

Tuition Assistance

Life & Disability Insurance

Employee Referral Awards

Job summary

Novo Nordisk in Durham, NC is seeking a validation professional to plan, manage and perform low to moderately complex validation projects and activities. You will support engineers with change requests and investigations, and collaborate with IT, Metrology and other stakeholders to ensure quality and cost efficiency.

The role requires a Bachelor’s degree in engineering or related field with 2+ years in validation for pharma or medical devices; travel up to 10% may be required.

Qualifications

• Bachelor’s degree in engineering or related field and 2+ years in validation in pharma or medical devices.
• Experience with cGMP documentation and regulatory requirements preferred.
• Strong communication and cross-functional teamwork skills.

Responsibilities

• Plan, manage & perform low to moderately complex validation projects.
• Support engineers with change requests and deviation investigations.
• Collaborate with IT, Metrology and other stakeholders to ensure quality and cost effectiveness.
• Review and approve validation documents and specifications for accuracy.
• Support change control and root cause analysis to prevent reoccurrence.
• Adhere to NNWay and safety/environmental requirements.

Skills

Validation methods

Quality documentation

Root cause analysis

Cross-functional collaboration

Equipment validation

Education

Bachelor’s degree in engineering or related field

Associate’s degree in engineering or related field

High school diploma or equivalent

Tools

Ellab Validator

Microsoft Word

Microsoft Excel

Job description

Novo Nordisk in Durham, NC is seeking a validation professional to plan, manage and perform low to moderately complex validation projects and activities. You will support engineers with change requests and investigations, and collaborate with IT, Metrology and other stakeholders to ensure quality and cost efficiency.

The role requires a Bachelor’s degree in engineering or related field with 2+ years in validation for pharma or medical devices; travel up to 10% may be required.