Engineer, Validation Job Description: Position Summary The Engineer, Validation provides validation support to Immunotherapy Production, Quality Control and Plant Engineering. This role also provides activity updates to Validation Manager on a regular basis to ensure compliance issues are being met. Essential Functions (ES) and Responsibilities • Develop, review, and approved technical documents such as qualification protocols (IQ/OQ/PQ), finalreports, change controls, SOPs, deviations, etc. • Manager, schedule, coordinate, and execute assigned qualification or validation activities to ensuretimely completion of the validation plan in coordination with the system owner. • Thesequalification/validation activities include facilities, utilities, equipment, and computer systems. • Support the validation strategy used at ADMA Biologics ensuring it is harmonized with regulatorystandards and current good manufacturing practices. • Support maintaining all process and laboratory equipment, facilities, and critical systems/utilities in aqualified/validated state. • Assist in the investigation of deviations encountered during the execution of validation protocols andprovide documentation to support such an effort. • Reviews executed protocols for completeness, cGxP compliance, data acceptability, and data integrity. • Supports the site periodic reviews and requalification programs. • Works with other departments to troubleshoot equipment. • Interact with FDA investigators regarding validation compliance issues and regulatory requirements. • Coordinate and support validation activities with appropriate departments and contract validation firmemployees. • Monitor validation activities or contract employees assigned to validation projects Job Responsibilities or Job Requirements Competencies FDA Adherence Experience Requirements Education Requirements: Bachelor's degree in science or engineering. Experience Requirements: 3+ years validation experience in a cGMP, Pharmaceutical/Biological manufacturing environment. Preferred Experience Compliance Requirements (ES)