Equipment Validation Engineer

Validation Engineer (Equipment) Location: Sinking Springs, PA Duration: Open (long term) The Validation Engineer will provide validation and compliance consulting and project support on various technology development and implementation projects, including planning, solution design, testing, and support. Support validation activities for systems in the various technical focus areas; Developing and managing GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance Testing, Requirements Traceability Matrix, Validation Summary Reports, Standard Operating Procedures, Change Control Documentation, and Risk Assessment reports; Write and execute IQ and OQ protocols; Hands on experience working with Bruderer Press Assist in the validations of process equipment, facilities, systems, and utilities Provides technical support to Development and QC groups on cGMP implementation and validation of manufacturing equipment for new processes Assist in the validation maintenance program for all process equipment, utilities, systems, and facilities Support the validation of new processes for manufacturing, development, and quality control Assist in making system improvements in conjunction with Manufacturing, Facilities, Quality Assurance, Validation and Regulatory Communicating with necessary vendors to ensure project requirements are being met; Conducting system compliance reviews; Managing and coordinating all aspects of the validation activities, including project planning, developing validation strategies, document development and document reviews; Overseeing system change requests and associated documentation; Maintaining SOPs pertaining to the Quality Management System; Utilization of a risk-based approach (GAMP5) to determine the validation.