Onsite Validation Engineer - Pharma & Biotech CQV Expert

KKR Consulting; North Carolina; On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A leading consulting firm in North Carolina is hiring a Validation Engineer to oversee CQV life cycle activities in the pharmaceutical industry. The ideal candidate will possess a Bachelor’s degree in Engineering and have extensive CQV experience, ideally within a regulated environment. Key responsibilities include managing validation projects, preparing documentation, and ensuring regulatory compliance. Benefits include medical, vision insurance, and a 401(k). This position offers a hands-on opportunity to work with cross-functional teams to drive success.

Qualifications

• Strong background in the pharmaceutical or biotech industry.
• Hands-on technical expertise in commissioning and validation.
• Experience with documentation and regulatory compliance.

Responsibilities

• Lead and execute CQV life cycle activities for various systems.
• Prepare and review CQV documentation: protocols and reports.
• Perform risk assessments and support mitigation strategies.
• Ensure compliance with FDA, EMA, and ICH regulations.
• Interface with cross-functional teams including engineering and QA.
• Support deviations, CAPAs, and change controls.
• Coordinate with contractors and vendors for validation projects.
• Manage multiple validation projects within budget and schedule.

Skills

CQV experience in pharma/biotech industry

Strong understanding of validation principles

Excellent documentation and technical writing skills

Ability to work independently

Education

Bachelor’s degree in Engineering (Mechanical, Chemical, Biomedical, or related field)

Tools

Knowledge of regulatory requirements (FDA 21 CFR Part 11, Part 210/211)

Experience with qualification of utilities and equipment

Job description

A leading consulting firm in North Carolina is hiring a Validation Engineer to oversee CQV life cycle activities in the pharmaceutical industry. The ideal candidate will possess a Bachelor’s degree in Engineering and have extensive CQV experience, ideally within a regulated environment. Key responsibilities include managing validation projects, preparing documentation, and ensuring regulatory compliance. Benefits include medical, vision insurance, and a 401(k). This position offers a hands-on opportunity to work with cross-functional teams to drive success.