Sr CQV Engineer / Sr Validation Engineer

Senior Validation Engineer / CQV Specialist

Location: Greenville, NC / Holly Springs, NC
Employment Type: Full-Time, On-Site
Salary Range: $70,000-$120,000/year

Position Summary

A leading pharmaceutical manufacturing organization is seeking a few Senior Validation Engineers / CQV Specialists to support commissioning, qualification, and validation activities for critical systems and processes. These rolee ensures compliance with regulatory standards and drives continuous improvement in a GMP-regulated environment.

Key Responsibilities

• Develop and execute validation documentation for equipment and processes
• Support sterility assurance and related validation activities
• Maintain project timelines and coordinate with cross-functional teams
• Review technical documents and provide compliance input
• Assist with troubleshooting and process improvements
• Ensure adherence to cGMP and regulatory requirements

Qualifications

• Bachelor's degree in engineering, life sciences, or related field
• 5+ years of experience in pharmaceutical or biotech validation
• Hands-on experience with commissioning, qualification, and validation protocols
• Familiarity with GMP regulations and FDA compliance standards
• Strong technical writing and problem-solving skills
• Ability to work onsite in Greenville, NC or Holly Springs, NC

Physical & Technical Requirements

• Ability to work in a sterile manufacturing environment
• Must pass required visual acuity and safety qualifications
• Proficiency in Microsoft Word and basic Excel