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ABDS, Inc is currently seeking forValidation Enginner JOB RESPONSIBILITIES: Support all aspects of the Validation Life Cycle from design through operation and improvement as required for all Teva Biologics validation functions. Responsible for the preparation of site validation documentation such as qualification protocols, validation master plans, risk assessments and periodic reviews. Coordinate and execute approved process validation, IQ, OQ and PQ protocols for the Biologics Manufacturing Facility (BMF), and GMP/GLP laboratories supporting large molecule testing Prepare reports using data from Process Validation, In-process Manufacturing testing In-process QC testing, and Finished Product QC testing Prepare reports using IQ, OQ, PQ, and Commissioning monitoring and test data Ensure validation testing performed by vendors is complete and accurate, work with vendors for issue resolution and validation deviation reporting. Represent validation in multi-disciplinary teams focused on production facility build and laboratory move activities (working with commissioning, validation, and computerized system validation Support the revalidation program. Ensure site alignment with corporate standards and cGMP guidelines. Upkeep of validation standard operating procedures. Authoring and revising procedures within the electronic documentation management system. Attends regular/recurring meetings to support the production facility during campaigns. Technically independent and maintains up-to-date knowledge of validation standards and regulatory compliance requirements. Independently contributes to development of new site validation standards. Work independently and/or with subject matter experts (SME) to implement and/optimize key validation and quality initiatives. Work with QA/Manufacturing group members to initiate and implement corrective and preventive actions. Provides weekly and/or monthly project status reports to Management Represent BOSS in regulatory agency inspections as required. Support continuous improvement projects and activities. Regular reporting to QA and Manufacturing Management via updates and presentations. Attend design meetings, and factory acceptance tests at vendor sites. Attends meetings to provide validation input for new projects, and attends critical utility/environmental monitoring excursion team meetings. Ensures training is up to date, provides training for validation contractors.