Sr CQV Engineer / Sr Validation Engineer Job at EPM Scientific, Holly Springs, NC

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  • EPM Scientific
  • Holly Springs, NC

Job Description

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

Job Tags

Full time,

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