Pharma Validation Specialist I/II – Process & Change

Novo Nordisk; Durham (NC); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Health Insurance

Tuition Assistance

Paid holidays

8% 401K company match

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 engineers with change requests and deviation investigations, collaborate with IT and other stakeholders, and ensure adherence to quality, cost and budget targets.

You will engage in revalidation activities, review validation documentation, and participate in audits, inspections, and continuous improvement initiatives.

Qualifications

• Bachelor’s degree in engineering, pharmaceutical sciences or related field required.
• Minimum 2 years of validation experience in pharmaceutical or medical device industry.
• Alternative education paths with 4+ years (assoc) or 6+ years (HS) may be considered.
• Knowledge of cGMP documentation and quality concepts preferred.
• Experience with core validation areas (equipment, sterilization, cleaning) preferred.
• Strong communication skills preferred.

Responsibilities

• Perform, review and approve validation/revalidation tasks.
• Review and approve documents per regulations.
• Collaborate with cross-functional teams to schedule validation activities.
• Identify root causes of failures and implement corrective actions.
• Support change control and validation procedures.
• Ensure data meets acceptance criteria.

Skills

Communication skills

Cross-functional collaboration

Root cause analysis

Quality mindset

Problem solving

Education

Bachelor’s degree in engineering or related

Associate’s degree in engineering (4+ years)

High school diploma (6+ years)

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 engineers with change requests and deviation investigations, collaborate with IT and other stakeholders, and ensure adherence to quality, cost and budget targets.

You will engage in revalidation activities, review validation documentation, and participate in audits, inspections, and continuous improvement initiatives.