Validation Engineer

Validation Engineer – Injection Molding

Location: Buffalo Grove Il
Hire Type: Contract
Shift: 1st Shift | Monday–Friday
Compensation: $55–$65/hour

Overview

We are seeking a hands-on Validation Engineer with experience supporting plastic injection molding manufacturing within a regulated environment. This individual will lead equipment, process, and manufacturing validations while partnering closely with Manufacturing Engineering, Quality, Operations, and Automation teams to ensure new and existing molding processes meet quality and regulatory requirements.

The ideal candidate will have experience developing and executing IQ/OQ/PQ protocols, validating injection molding equipment and processes, troubleshooting manufacturing issues, and supporting continuous improvement initiatives in a medical device, pharmaceutical, or similarly regulated manufacturing environment.

Key Responsibilities
Develop, execute, and approve IQ, OQ, and PQ validation protocols for injection molding equipment, automation, and manufacturing processes.
Lead validation activities for new product introductions, equipment installations, process transfers, and manufacturing changes.
Validate injection molding processes including process windows, machine qualifications, tooling, auxiliary equipment, and automation systems.
Perform risk assessments utilizing FMEA and other risk management tools.
Investigate validation failures, process deviations, and nonconformances while implementing effective corrective actions.
Analyze process capability, statistical data, and validation results to ensure robust manufacturing processes.
Collaborate with Manufacturing Engineering to optimize molding parameters, cycle times, and process performance.
Support mold qualifications, process characterization, and production readiness activities.
Prepare validation reports, technical documentation, protocols, and supporting engineering documentation.
Participate in equipment FAT/SAT activities when applicable.
Ensure validation documentation complies with FDA, ISO 13485, GMP, and internal quality standards.
Support CAPA investigations, change control activities, and regulatory audits.
Work cross-functionally with Engineering, Quality, Production, Tooling, Automation, and Regulatory Affairs teams.

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

Preferred Qualifications
Medical device, pharmaceutical, or highly regulated manufacturing experience.
Experience with automated manufacturing equipment, robotics, vision systems, and PLC-controlled equipment.
Knowledge of FDA 21 CFR Part 820, ISO 13485, GMP, and GAMP guidance.
Experience with injection mold qualification, tooling validation, and mold transfers.
Familiarity with cleanroom manufacturing environments.
Experience supporting CAPA, NCR investigations, and change control processes.
Working knowledge of Minitab or other statistical software.