Equipment Validation Engineer
Listed on 2026-02-12
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Engineering
Quality Engineering, Validation Engineer, Process Engineer, Pharma Engineer
Overview
KKR Consulting partners with businesses to solve challenges, streamline processes, and achieve lasting success. We specialize in providing tailored consulting services across Aerospace, Medical Devices, Automotives, Pharmaceuticals, and Biotechnology industries, helping clients drive innovation, enhance operations, and achieve sustainable growth.
PositionPosition
:
Equipment Validation Engineer
Location
:
Wisconsin
Our client is seeking three Process / Equipment Validation Engineers to support the full lifecycle qualification and validation of 50 + pieces of silicone injection molding equipment. These roles will be responsible for supporting new equipment installation, tooling installation or replacement, and execution of commissioning and qualification activities. Once equipment is installed and qualified, the engineers will author and execute all required validation documentation to support compliant manufacturing operations.
This is a small, fast-paced organization, and the ideal candidate is a self-starter who can take ownership of work streams, proactively identify gaps, and drive validation activities forward without needing constant direction.
- 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.
- 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.
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