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
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