What are the responsibilities and job description for the Validation Engineer position at Katalyst Healthcares and Lifesciences?
Job Summary:
Roles & Responsibilities:
Requirements / Qualifications:
- 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.
- 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.