Validation Engineer – Injection Molding

About the role

Own the validation behind every molded part that ships. As a hands-on Validation Engineer specializing in plastic injection molding, you'll lead equipment, process, and manufacturing validations in a regulated environment. You'll serve as the technical bridge between Manufacturing Engineering, Quality, Operations, and Automation, driving IQ/OQ/PQ protocols from draft to approval and ensuring processes meet quality and regulatory standards.

Responsibilities

• Build, run, and approve IQ/OQ/PQ protocols for injection molding equipment, automation, and manufacturing processes
• Lead validation for new product introductions, equipment installations, process transfers, and manufacturing changes
• Validate molding process windows, machine qualification, tooling, auxiliary equipment, and automation systems
• Conduct risk assessments using FMEA and other structured risk tools
• Investigate validation failures, process deviations, and nonconformances, driving corrective actions
• Translate process capability and statistical data into decisions that improve manufacturing robustness
• Partner with Manufacturing Engineering to optimize molding parameters, cycle times, and process performance
• Support mold qualifications, process characterization, and production readiness
• Own validation reports, technical documentation, protocols, and engineering records
• Participate in FAT/SAT activities for equipment validation
• Maintain validation documentation aligned with FDA, ISO 13485, GMP, and internal quality standards
• Support CAPA investigations, change control, and regulatory audits
• Collaborate cross-functionally with Engineering, Quality, Production, Tooling, Automation, and Regulatory Affairs

Requirements

• Bachelor's degree in Engineering or a related technical field
• 3+ years of validation engineering experience in a manufacturing environment
• Hands-on experience validating plastic injection molding processes and equipment
• Solid understanding of IQ/OQ/PQ methodology and validation lifecycle documentation
• Experience with process validation, equipment qualification, and process development
• Familiarity with scientific molding principles and process optimization
• Comfort with statistical analysis tools and process capability studies
• Working knowledge of PFMEA/FMEA risk methodologies
• Strong technical writing and documentation skills

Nice to Have

• Experience in medical device, pharmaceutical, or other highly regulated manufacturing
• Experience with automated equipment, robotics, vision systems, or PLC-controlled systems
• Knowledge of FDA 21 CFR Part 820, ISO 13485, GMP, and GAMP guidance
• Injection mold qualification, tooling validation, or mold transfer experience
• Exposure to cleanroom manufacturing
• CAPA, NCR investigation, or change control experience
• Working knowledge of Minitab or similar statistical software