KKR Consulting · 6 hours ago
CSV Engineer
North Carolina, United States
Contract
Onsite
Senior Level
5+ years expKKR Consulting partners with businesses to solve challenges and streamline processes. They are seeking an experienced Computer System Validation (CSV) Engineer to support facility-based projects and ensure compliance with regulatory standards throughout the system lifecycle.
Staffing & Recruiting
Hiring Manager
Dyutipriya Sarkar
Responsibilities
Develop, review, and approve User Requirement Specifications (URS), functional specifications, and design documentation
Perform and document CSV activities in accordance with GAMP 5, FDA, EMA, and 21 CFR Part 11 guidelines
Conduct look-checks and verification during equipment installation and startup to ensure alignment with specifications
Support OEM equipment qualification and vendor documentation reviews for compliance and completeness
Interface with facilities, OEMs, and automation teams to ensure seamless integration and validation of systems (including DeltaV)
Prepare, execute, and review validation deliverables such as IQ/OQ protocols, test scripts, and summary reports
Provide change control and deviation management support as related to CSV deliverables
Ensure inspection readiness by maintaining accurate documentation and adhering to company SOPs and regulatory expectations
Qualification
Required
Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field (or equivalent experience)
Minimum 5 years of hands-on experience in CSV within a pharmaceutical, biotech, or regulated manufacturing environment
Strong knowledge of CSV regulations and industry guidance (GAMP 5, FDA, EMA, 21 CFR Part 11, Annex 11)
Experience with DeltaV system validation (no coding required)
Familiarity with facility and OEM equipment validation/qualification
Proven ability to review technical specs and perform compliance checks during installation
Excellent documentation, organizational, and communication skills
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