Senior Validation SME – Pharma Systems

Novo Nordisk A/S; Petersburg (VA); On-site; USD 90,000 - 135,000; Full time

Benefits offered by this job

Health Insurance and benefits from day

401K with company match

Paid time off and holidays

Tuition Assistance

Job summary

Join Novo Nordisk in Petersburg, VA as a Subject Matter Expert for validation activities across high-complexity projects. You will support engineers, write change requests and deviations, and coordinate with IT, metrology and stakeholders to ensure timely, quality deliverables.

You will mentor junior team members, lead investigations, and ensure compliance with regulatory requirements while advancing Novo Nordisk's SMOL and ET initiatives.

Qualifications

• Bachelor's Degree in Engineering, Pharmaceutical Sciences or related field required with 7+ years of validation experience.
• Experience in quality concepts including technical and compliance review of validation documents is required.
• Experience in core validation areas (equipment, sterilization, cleaning, process clean, utilities or computer validation) is required.
• cGMP documentation practices and regulations knowledge is required.

Responsibilities

• Provide SME knowledge and guidance on validation activities, initiatives and projects.
• Lead and perform validation/revalidation activities and review documents.
• Identify and remediate validation compliance gaps within the department.
• Review and approve validation protocols, specifications and quality documents for accuracy and compliance.
• Lead root cause analysis and implement corrective actions to prevent recurrence.
• Collaborate with multiple departments to plan and execute revalidation assignments.

Skills

Validation expertise

Root cause analysis

Cross-functional collaboration

Quality systems

Documentation review

Communication skills

Education

Bachelor's in Engineering/Pharmaceuticals

7+ years validation experience

Tools

Ellab Validator

Job description

Join Novo Nordisk in Petersburg, VA as a Subject Matter Expert for validation activities across high-complexity projects. You will support engineers, write change requests and deviations, and coordinate with IT, metrology and stakeholders to ensure timely, quality deliverables.

You will mentor junior team members, lead investigations, and ensure compliance with regulatory requirements while advancing Novo Nordisk's SMOL and ET initiatives.