Process Validation Engineer

Job Title: Process Validation Engineer Location: Warsaw, IN (Onsite) Experience Required: 3–5 years

Role Overview

We are looking for a Process Validation Engineer to lead validation strategy and execution for medical device manufacturing processes. The role ensures compliance with regulatory standards while optimizing processes and driving continuous improvement across multiple manufacturing technologies.

Key Responsibilities

Validation Strategy & Execution: Develop and execute IQ/OQ/PQ protocols, risk assessments, and validation plans for equipment and processes.

Regulatory Compliance: Ensure adherence to FDA 21 CFR 820, ISO 13485, and applicable standards; support and participate in internal and external audits.

Data Analysis & Reporting: Compile validation data, perform trend analysis, and prepare comprehensive reports with improvement recommendations.

Cross-Functional Collaboration: Partner with Manufacturing, QA, Engineering, and other functions to troubleshoot issues, implement cleaning strategies, and provide technical support.

Documentation Ownership: Create, maintain, and improve controlled documents such as prints, SOPs, BOMs, and routers.

Process Engineering Support: Support manufacturing processes including machining, finishing, forging, casting, cleaning, heat treating, bonding, and molding.

Feasibility & Costing: Conduct feasibility studies, estimate product costs, and assess capital equipment, capacity, and capability requirements.

Process Optimization: Establish and improve methods to meet quality and performance requirements; evaluate and select optimal processes and machining methods.

Project Management: Develop and manage project plans and schedules; communicate project status and plans across teams.

Qualification/Validation Execution: Lead end-to-end equipment qualification and process validation projects.