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.