Job summary
Job post source
This job is directly from KKR Consulting
Job overview
The CQV Validation Engineer at KKR Consulting is responsible for leading commissioning, qualification, and validation activities in pharmaceutical or biotech industries to ensure regulatory compliance and process integrity.
Responsibilities and impact
The engineer will lead CQV lifecycle activities, prepare and review validation documentation, perform risk assessments, ensure compliance with FDA and EMA regulations, collaborate with cross-functional teams, manage deviations and change controls, coordinate with contractors, and oversee multiple validation projects.
Compensation and benefits
The position offers medical, vision, and dental insurance along with a 401(k) retirement plan.
Experience and skills
Candidates must have a bachelor's degree in engineering, 5–8 years of CQV experience in pharma/biotech, strong validation knowledge, experience with utilities and equipment qualification, excellent documentation skills, and regulatory knowledge.
Work environment and culture
The role is onsite in Cary, NC, requiring hands-on technical expertise and the ability to work independently in a fast-paced environment.
Company information
KKR Consulting provides tailored consulting services across multiple industries including aerospace, medical devices, pharmaceuticals, and biotechnology, focusing on innovation and operational excellence.
Job location and travel
The job is located onsite in Cary, North Carolina.
Unique job features
The role involves managing multiple projects and working with various stakeholders including contractors and vendors in a regulated cGMP environment.
Company overview
KKR Consulting is a global investment firm specializing in private equity, credit, and real assets, alongside offering strategic consulting services to businesses. They generate revenue through investment management fees, performance-based incentives, and returns from their portfolio companies. Founded in 1976 as Kohlberg Kravis Roberts & Co., KKR has a rich history of pioneering leveraged buyouts and expanding into diverse asset classes and advisory services. Candidates should note KKR’s reputation for innovation, its client-focused approach, and its extensive global network, which underpins its success in delivering tailored financial and strategic solutions.
How to land this job
Tailor your resume to emphasize your 5-8 years of CQV experience in pharmaceutical or biotech industries, focusing on commissioning, qualification, and validation of equipment and systems in cGMP environments.
Highlight your expertise in preparing and reviewing CQV documentation such as URS, DQ, FAT, SAT, IQ, OQ, and PQ protocols and reports, along with your knowledge of FDA, EMA, and ICH regulatory compliance.
Apply through multiple channels including KKR Consulting's corporate careers page and LinkedIn to maximize your application visibility.
Connect with current CQV or validation engineers at KKR Consulting on LinkedIn, using ice breakers like asking about recent validation projects or insights on CQV challenges in biotech to build rapport.
Optimize your resume for ATS by incorporating keywords from the job description like 'CQV Validation Engineer,' 'cGMP,' 'FDA 21 CFR Part 11,' 'risk assessments,' and 'ASTM E2500' to ensure it passes initial screenings.
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