What are the responsibilities and job description for the Validation Engineer - Medical Devices position at CARIN Alliance?
Role: Validation Engineer responsible for supporting qualification and validation of manufacturing lines to ensure compliance with medical device standards and operational readiness.
Responsibilities: Develop, update, and execute qualification protocols including Installation, Operational, and Performance Qualification (IOPQ). Collaborate with SMEs and cross-site teams to gather requirements, translate them into test cases, and ensure consistent execution. Navigate complex Quality Management Systems (QMS) to ensure documentation compliance. Support IOPQ activities through international travel, participate in dry runs and live tests, generate qualification reports, and maintain clear communication with stakeholders. Provide regular status updates, flag risks, and produce final documentation.
Qualifications & Skills: Mid-senior level experience in validation within medical device manufacturing, strong collaboration and communication skills, proficiency in protocol development and quality systems, and ability to work across global teams. Ability to travel internationally is expected.
Responsibilities: Develop, update, and execute qualification protocols including Installation, Operational, and Performance Qualification (IOPQ). Collaborate with SMEs and cross-site teams to gather requirements, translate them into test cases, and ensure consistent execution. Navigate complex Quality Management Systems (QMS) to ensure documentation compliance. Support IOPQ activities through international travel, participate in dry runs and live tests, generate qualification reports, and maintain clear communication with stakeholders. Provide regular status updates, flag risks, and produce final documentation.
Qualifications & Skills: Mid-senior level experience in validation within medical device manufacturing, strong collaboration and communication skills, proficiency in protocol development and quality systems, and ability to work across global teams. Ability to travel internationally is expected.