Bachelor's degree in engineering (Electrical, Mechanical, Biomedical, Manufacturing, or related field).
5+ years of experience in Test Engineering or V&V within regulated industries.
Hands-on experience qualifying automated manufacturing test equipment.
Strong knowledge of IQ, OQ, and PQ validation methodologies.
Proficiency with LabVIEW and NI Test Stand.
Experience preparing validation documentation and reports.
Strong analytical and troubleshooting skills.
Responsibilities
Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for test equipment.
Execute V&V activities to ensure systems meet requirements.
Qualify and validate automated manufacturing test equipment.
Develop and review validation protocols and test plans.
Conduct functional testing to verify equipment performance.
Utilize LabVIEW and NI Test Stand for test development and validation.
Collaborate with cross-functional teams to resolve technical issues.
Benefits
Continuous improvement initiatives to enhance processes.
Opportunities for collaboration across multiple engineering disciplines.
Exposure to regulated industries such as Medical Devices and Pharmaceuticals.
Thorough training in sophisticated test and validation technologies.
Full Job Description
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.
The ideal candidate will have hands-on experience in LabVIEW, NI Test Stand, IQ/OQ/PQ validation, functional testing, and preparation of validation documentation to support manufacturing equipment qualification and compliance.
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.
