CQV Engineer
Job in
Greensboro, Guilford County, North Carolina, 27497, USA
Listed on 2026-02-12
Listing for:
KKR Consulting
Full Time
position Listed on 2026-02-12
Job specializations:
-
Engineering
Validation Engineer, Pharma Engineer, Quality Engineering
Job Description & How to Apply Below
Overview
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: CQV Engineer
Location: North Carolina
Job SummaryThe CQV Engineer will support commissioning, qualification, and validation activities for pharmaceutical equipment, utilities, and systems in compliance with cGMP and regulatory requirements.
Key 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, clean rooms, 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.
- 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 (Track Wise, Veeva, Master Control).
- Experience with sterile or biologics manufacturing.
- Familiarity with ASTM E2500 and ISPE guidelines.
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