Sr CQV Engineer / Sr Validation Engineer (Holly Springs)EPM Scientific • Holly Springs, NC, United States

Sr CQV Engineer / Sr Validation Engineer (Holly Springs)

EPM Scientific • Holly Springs, NC, United States

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[job_card.full_time]

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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 roles ensure 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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