Katalyst Healthcares & Life Sciences
Validation Support Engineer
Katalyst Healthcares & Life Sciences, Boston, Massachusetts, United States, 02108
Validation Support Engineer
We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment. The role focuses on ensuring compliance with FDA regulations 21 CFR Part 11, 210, 211, 820, GAMP5 methodologies, and internal quality standards. Responsibilities: Develop/update validation protocols and reports, conduct risk assessments, and ensure all validation activities are documented and compliant with regulatory requirements.
We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment. The role focuses on ensuring compliance with FDA regulations 21 CFR Part 11, 210, 211, 820, GAMP5 methodologies, and internal quality standards. Responsibilities: Develop/update validation protocols and reports, conduct risk assessments, and ensure all validation activities are documented and compliant with regulatory requirements.