Validation Specialist: Equipment, Cleaning & Process

BioSpace; Durham (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health Insurance

Paid Time Off

Retirement Match

Parental Leave

Tuition Assistance

Job summary

Novo Nordisk is seeking a validation professional to plan, manage and perform low to moderately complex validation projects in our Durham, NC facility. You will support engineers with change requests and deviation investigations, collaborating across IT, Metrology and other stakeholders to ensure timely, compliant deliverables.

The role requires a BS in engineering or a related field with 2+ years of validation experience in pharma/medical devices, or an equivalent combination.

Qualifications

• BS in engineering or related field with 2+ years validation experience in pharma/medical devices
• Associate’s degree with 4+ years validation experience
• High school diploma with 6+ years validation experience
• Experience with quality concepts and document reviews
• Experience in core validation areas (equipment, sterilization, cleaning, process and computer validation)
• Knowledge of cGMP documentation practices and regulations
• Proficiency with MS Word and Excel
• Strong communication and cross-functional collaboration
• Familiarity with root-cause analysis and problem-solving techniques

Responsibilities

• Perform, review and approve validation/revalidation
• Review and approve documents per regulatory requirements
• Collaborate to review/approve protocols for systems/processes
• Identify root causes of failures and implement corrective actions
• Ensure protocol data meets acceptance criteria
• Support validation change controls and process improvements
• Author and review validation procedures and quality documents
• Coordinate with IT, Metrology and other stakeholders
• Operate with NNWay and Lean thinking
• Adhere to safety and environmental requirements
• Other duties as assigned

Skills

Root cause analysis

Cross-functional teamwork

Quality concepts

cGMP knowledge

MS Word

MS Excel

Problem-solving

Communication skills

Validation methods

Education

Bachelor’s degree in engineering or related field

Associate’s degree in engineering or related field

High school diploma + 6 years validation experience

Tools

Ellab Validator

Temperature mapping equipment

Job description

Novo Nordisk is seeking a validation professional to plan, manage and perform low to moderately complex validation projects in our Durham, NC facility. You will support engineers with change requests and deviation investigations, collaborating across IT, Metrology and other stakeholders to ensure timely, compliant deliverables.

The role requires a BS in engineering or a related field with 2+ years of validation experience in pharma/medical devices, or an equivalent combination.