Equipment Validation Engineer jobs in United States
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KKR Consulting · 8 hours ago

Equipment Validation Engineer

KKR Consulting partners with businesses to solve challenges and streamline processes. They are seeking three Equipment Validation Engineers to support the full lifecycle qualification and validation of silicone injection molding equipment, ensuring compliance with manufacturing operations.

Staffing & Recruiting
Hiring Manager
Satya CH
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Responsibilities

Support installation, commissioning, and qualification (IQ/OQ/PQ) of silicone injection molding equipment
Assist with new tooling installation and replacement of existing tooling on molding machines
Lead and execute equipment qualification protocols, including test execution and data analysis
Author and review validation documentation, including URS, risk assessments, IQ/OQ/PQ protocols, reports, and traceability matrices
Support process validation activities following equipment qualification
Collaborate with Engineering, Manufacturing, Quality, and external vendors to ensure validation timelines are met
Ensure validation activities comply with GMP, ISO, and internal quality system requirements

Qualification

Equipment qualificationValidation processesISO 13485 complianceIQ/OQ/PQ protocolsGMP familiaritySelf-starterCollaboration skills

Required

Experience as a Process / Equipment Validation Engineer in regulated manufacturing environments
Strong understanding of equipment qualification and validation processes
5+ years of experience
Experience working in ISO 13485–compliant quality systems, preferably in a medical device manufacturing environment
Experience authoring and executing IQ/OQ/PQ protocols and reports
Familiarity with GMP and quality system requirements

Benefits

Medical insurance
Vision insurance
Dental insurance
401(k)

Company

KKR Consulting

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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.

Funding

Current Stage
Early Stage
Company data provided by crunchbase