Validation Engineer

Job Summary

We are seeking an experienced Test/Validation Engineer with expertise in manufacturing validation, automated test equipment qualification, and Verification & Validation (V&V) within regulated industries.

Roles & Responsibilities

• Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing test equipment.
• Execute Verification & Validation (V&V) activities to ensure manufacturing systems and equipment meet predefined requirements.
• Qualify and validate automated manufacturing test equipment used in production environments.
• Develop, execute, and review validation protocols, test plans, traceability matrices, and validation reports.
• Conduct functional testing to verify equipment performance and product quality.
• Utilize LabVIEW and NI Test Stand for automated test development, execution, and validation.
• Support manufacturing equipment qualification activities in accordance with quality and regulatory requirements.
• Collaborate with Manufacturing, Quality, Engineering, and Validation teams to resolve technical issues and ensure compliance.
• Maintain complete and accurate validation documentation in accordance with company procedures and regulatory standards.
• Participate in continuous improvement initiatives to enhance validation processes and manufacturing efficiency.

Requirements / Qualifications

• Bachelor's degree in engineering (Electrical, Mechanical, Biomedical, Manufacturing, or related field).
• 5+ years of experience in Test Engineering, Manufacturing Validation, or Verification & Validation (V&V) within regulated industries.
• Hands-on experience qualifying automated manufacturing test equipment.
• Strong knowledge and practical experience with IQ, OQ, and PQ validation methodologies.
• Experience performing Functional Testing and Verification & Validation (V&V) activities.
• Proficiency with LabVIEW and NI Test Stand.
• Experience preparing validation protocols, traceability matrices, validation reports, and supporting documentation.
• Familiarity with manufacturing equipment qualification processes.
• Strong analytical, troubleshooting, and problem-solving skills.
• Excellent documentation, communication, and cross-functional collaboration skills.
• Experience working in regulated environments such as Medical Devices, Life Sciences, Pharmaceutical, or FDA/GMP-regulated manufacturing is preferred.

Pay

Negotiable based on experience and qualifications.

Schedule

Full-time position.