KKR Consulting · 4 hours ago
CQV Validation Engineer
Cary, NC
Contract
Onsite
Senior Level
5+ years expKKR Consulting is a firm that partners with businesses across various industries to provide tailored consulting services. They are seeking an experienced CQV Validation Engineer to lead and execute CQV life cycle activities in the pharmaceutical or biotech industry, ensuring compliance with regulatory standards and managing multiple validation projects.
Staffing & Recruiting
Hiring Manager
Satya CH
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
Qualification
Required
Bachelor's degree in Engineering (Mechanical, Chemical, Biomedical, or related field)
5–8 years of 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
Dental insurance
401(k)
Company
KKR Consulting
At KKR Consulting, we collaborate with businesses across a wide range of industries to tackle complex challenges, fuel sustainable growth, and connect them with exceptional talent.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase