KKR Consulting · 13 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.
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
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
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 StageCompany data provided by crunchbase