Senior Validation Lead – Equipment & Process Systems

BioSpace; Petersburg (VA); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401K with company match

Parental & family leave

Tuition assistance

Life & Disability Insurance

Employee Referral Awards

Job summary

Novo Nordisk seeks a Senior Validation SME to plan, manage and perform high-complexity validation activities for our Petersburg, Virginia site. You will support engineers with change requests, deviations, and validation plans across equipment, sterilization, cleaning, and computer validation, coordinating with IT and metrology.

You will mentor junior staff, lead investigations, ensure protocol data meets criteria, and drive improvements with a risk-based validation mindset while adhering to

Qualifications

• Bachelor’s Degree in Engineering, Pharmaceutical Sciences or related field; 7+ years of validation experience in pharma/medical devices.
• Alternative: Associate’s Degree with 9+ years of validation experience.
• Alternative: High School Diploma with 11+ years of validation experience.

Responsibilities

• Provide SME level guidance on validation activities and projects.
• Lead investigations and root-cause analyses for validation issues.
• Review and approve validation/revalidation and pse activities.
• Identify and remediate validation compliance gaps.
• Prepare and approve validation documents and protocols; support audits and inspections.

Skills

Validation

Root cause analysis

Quality systems

Project management

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Associate’s degree in engineering (alternative)

High School Diploma or equivalent (alternative)

Tools

Ellab Validator

Temperature mapping equipment

Microsoft Word

Microsoft Excel

Job description

Novo Nordisk seeks a Senior Validation SME to plan, manage and perform high-complexity validation activities for our Petersburg, Virginia site. You will support engineers with change requests, deviations, and validation plans across equipment, sterilization, cleaning, and computer validation, coordinating with IT and metrology.

You will mentor junior staff, lead investigations, ensure protocol data meets criteria, and drive improvements with a risk-based validation mindset while adhering to