Validation Engineer

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

Talent Acquisition Specialist @ KKR Consulting

KKR Consulting partners with businesses to solve challenges, streamline processes, and achieve lasting success. We specialize in providing tailored consulting services across Aerospace, Medical Devices, Automotives, Pharmaceuticals, and Biotechnology industries, helping clients drive innovation, enhance operations, and achieve sustainable growth.

Job Title: Validation Engineer

Location: NC (Onsite)

Job Summary

We are seeking an experienced Validation Engineer to join our team in Cary, NC. The ideal candidate will have a strong background in the pharmaceutical or biotech industry and experience in commissioning, qualification, and validation of equipment, systems, and processes in a regulated (cGMP) environment. This role is onsite and requires hands‑on technical expertise as well as documentation and regulatory compliance capabilities.

Key Responsibilities

• Lead and execute CQV life cycle activities for process equipment, utilities (clean and black), HVAC, and laboratory systems.
• Prepare and review CQV documentation: URS, DQ, FAT, SAT, IQ, OQ, PQ protocols and reports.
• Perform risk assessments (FMEA, GEP‑based assessments) and support implementation of mitigation strategies.
• Ensure compliance with FDA, EMA, and ICH regulations and cGMP practices.
• Interface with cross‑functional teams including engineering, QA, manufacturing, and automation.
• Support and troubleshoot deviations, CAPAs, and change controls related to CQV projects.
• Coordinate with contractors, vendors, and third‑party consultants to meet validation project timelines.
• Manage multiple validation projects and ensure successful execution within budget and schedule.

Required Qualifications

• Bachelor’s degree in Engineering (Mechanical, Chemical, Biomedical, or related field).
• CQV experience in the pharma/biotech industry.
• Strong understanding of validation principles (V‑model, ASTM E2500, ISPE Baseline Guides).
• Proven experience with qualification of utilities (WFI, Clean Steam, HVAC), equipment (autoclaves, bioreactors, chromatography skids, etc.), and lab instruments.
• Excellent documentation and technical writing skills.
• Knowledge of regulatory requirements (FDA 21 CFR Part 11, Part 210/211).
• Ability to work independently in a fast‑paced, dynamic environment.

Benefits

• Medical insurance
• Vision insurance
• 401(k)