KKR Consulting
Overview
KKR Consulting is seeking a
Cleaning Validation Engineer
to support GMP manufacturing operations within a biopharmaceutical environment. The engineer will lead and execute cleaning validation activities focused on
chromatography systems
and
LNP (Lipid Nanoparticle) skids , ensuring all cleaning processes meet FDA/EMA regulatory standards and maintain product integrity. Key Responsibilities
Develop, execute, and document
cleaning validation protocols and reports
in compliance with cGMP, FDA, and EMA requirements. Perform
risk assessments , define acceptance criteria, and establish sampling plans (swab and rinse methods). Lead and support
laboratory and manufacturing cleaning studies
to verify cleaning effectiveness. Troubleshoot cleaning validation issues and provide
technical input
for process and equipment improvements. Collaborate with
Manufacturing, QA, Validation, and Engineering
to ensure consistent cleaning strategy execution. Support
regulatory inspections
and ensure documentation readiness. Drive
continuous improvement
in cleaning validation processes, methods, and documentation practices. Focus Areas
Cleaning validation for
chromatography systems and LNP skids GMP-compliant cleaning strategy and data integrity Validation documentation, sampling methods, and acceptance criteria Cross-functional collaboration and regulatory support Qualifications
5+ years
of experience in cleaning validation within a GMP-regulated pharma or biotech environment. Strong understanding of
FDA/EMA cleaning validation guidelines
and contamination control principles. Hands-on experience with
chromatography, LNP skids, and related manufacturing systems. Proficient in authoring and reviewing
validation protocols, reports, and risk assessments. Excellent communication and documentation skills. Bachelor’s degree in
Engineering, Life Sciences, or related discipline. Top Skills
Cleaning Validation (Chromatography, LNP Systems) cGMP, FDA, EMA Compliance Validation Protocols & Reports (IQ/OQ/PQ) Cross-Functional Team Collaboration Seniority level
Mid-Senior level Employment type
Contract Location: Durham, NC • Salary: $100,000.00-$150,000.00
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KKR Consulting is seeking a
Cleaning Validation Engineer
to support GMP manufacturing operations within a biopharmaceutical environment. The engineer will lead and execute cleaning validation activities focused on
chromatography systems
and
LNP (Lipid Nanoparticle) skids , ensuring all cleaning processes meet FDA/EMA regulatory standards and maintain product integrity. Key Responsibilities
Develop, execute, and document
cleaning validation protocols and reports
in compliance with cGMP, FDA, and EMA requirements. Perform
risk assessments , define acceptance criteria, and establish sampling plans (swab and rinse methods). Lead and support
laboratory and manufacturing cleaning studies
to verify cleaning effectiveness. Troubleshoot cleaning validation issues and provide
technical input
for process and equipment improvements. Collaborate with
Manufacturing, QA, Validation, and Engineering
to ensure consistent cleaning strategy execution. Support
regulatory inspections
and ensure documentation readiness. Drive
continuous improvement
in cleaning validation processes, methods, and documentation practices. Focus Areas
Cleaning validation for
chromatography systems and LNP skids GMP-compliant cleaning strategy and data integrity Validation documentation, sampling methods, and acceptance criteria Cross-functional collaboration and regulatory support Qualifications
5+ years
of experience in cleaning validation within a GMP-regulated pharma or biotech environment. Strong understanding of
FDA/EMA cleaning validation guidelines
and contamination control principles. Hands-on experience with
chromatography, LNP skids, and related manufacturing systems. Proficient in authoring and reviewing
validation protocols, reports, and risk assessments. Excellent communication and documentation skills. Bachelor’s degree in
Engineering, Life Sciences, or related discipline. Top Skills
Cleaning Validation (Chromatography, LNP Systems) cGMP, FDA, EMA Compliance Validation Protocols & Reports (IQ/OQ/PQ) Cross-Functional Team Collaboration Seniority level
Mid-Senior level Employment type
Contract Location: Durham, NC • Salary: $100,000.00-$150,000.00
#J-18808-Ljbffr