KKR Consulting · 9 hours ago
CQV Engineer
North Carolina, United States
Contract
Onsite
Mid Level
3+ years expKKR Consulting partners with businesses to solve challenges and streamline processes. The CQV Engineer will support commissioning, qualification, and validation activities for pharmaceutical equipment, utilities, and systems in compliance with cGMP and regulatory requirements.
Staffing & Recruiting
Hiring Manager
Dyutipriya Sarkar
Responsibilities
Execute IQ/OQ/PQ for manufacturing equipment, utilities, and facilities
Support commissioning activities, system walkdowns, and turnover documentation
Author and execute validation protocols and reports
Support qualification of HVAC, cleanrooms, PW/WFI, clean steam, and compressed gases
Manage deviations, change controls, and CAPAs related to validation
Support CSV activities per GAMP 5 and 21 CFR Part 11 (as applicable)
Collaborate with Engineering, QA, Manufacturing, and Automation teams
Support audits, inspections, and requalification activities
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or related field
3–4 years CQV experience in a GMP pharmaceutical environment
Strong knowledge of cGMP, FDA 21 CFR 210/211, Part 11
Hands-on experience with IQ/OQ/PQ execution and GDP documentation
Experience using QMS/EDMS tools (TrackWise, Veeva, MasterControl)
Experience with sterile or biologics manufacturing
Familiarity with ASTM E2500 and ISPE guidelines
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