Validation Engineer – Injection Molding

Job Title:

Validation Engineer – Injection Molding

Employment Type:

W2 Contract Duration: 12+ Months

Job Summary:

Intellectt Inc. is seeking a Validation Engineer – Injection Molding to support plastic injection molding manufacturing within a regulated environment. The selected candidate will lead equipment, process, and manufacturing validation activities to ensure compliance with quality and regulatory requirements. This role partners closely with Manufacturing Engineering, Quality, Operations, Automation, and cross-functional teams to support new product introductions, process improvements, equipment qualifications, and manufacturing excellence.

• Develop, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for injection molding equipment, automation systems, and manufacturing processes.
• Lead validation activities for new equipment installations, process transfers, manufacturing changes, and new product introductions.
• Validate injection molding processes, including process windows, machine qualifications, tooling, auxiliary equipment, and automated manufacturing systems.
• Conduct risk assessments using FMEA or similar risk management methodologies.
• Investigate validation failures, process deviations, and nonconformances, and support appropriate corrective and preventive actions.
• Analyze validation data, statistical results, and process capability metrics to ensure robust manufacturing performance.
• Collaborate with Manufacturing Engineering to optimize molding parameters, cycle times, and overall process efficiency.
• Support mold qualification, process characterization, and production readiness activities.
• Prepare validation protocols, reports, engineering documentation, and technical records.
• Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) activities when applicable.
• Ensure validation documentation complies with applicable FDA regulations, ISO 13485, GMP requirements, and internal quality standards.
• Support CAPA activities, change control processes, and regulatory or quality audits.
• Collaborate effectively with Engineering, Quality, Production, Tooling, Automation, and Regulatory Affairs teams.

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

• Experience in medical device, pharmaceutical, or other highly regulated manufacturing environments.
• Experience with automated manufacturing equipment, robotics, vision inspection 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 transfer activities.
• Familiarity with cleanroom manufacturing environments.
• Experience supporting CAPA investigations, nonconformance investigations, and change control processes.
• Working knowledge of Minitab or similar statistical analysis software.

• Ability to work onsite in Buffalo Grove, Illinois during first shift, Monday through Friday.
• Ability to work in a manufacturing environment, including regulated production areas.
• Ability to review technical documentation, analyze data, and prepare detailed validation reports.
• Ability to collaborate effectively with cross-functional teams.
• Occasional overtime or schedule adjustments may be required based on project needs.
• Ability to comply with all applicable safety, quality, and company policies.