Puerto Rico
Experienced Lead Engineer with a demonstrated history of working in the biotechnology industry. Strong quality assurance professional skilled in Biotechnology, Software Documentation, U.S. Food and Drug Administration (FDA), Commissioning, and Validation.
• Review and approve Kneat documents including: DeltaV software FATs, SATs, Automation Commissioning Test Protocols, software OQs, and Software Installation Verification protocols. • Assist in resolving protocol execution issues using critical analysis and develop sound, reasonable solutions. • Assist with the development of system requirements and specifications to ensure requirements are testable and meet 21 CFR Part 11. • Support generation of Kneat documents. Review and approve Automation documentation including risk and impact assessments, computer systems validation plans, user requirements specifications, functional requirement specifications, traceability matrices, release reports, and all documents and deliverables within the scope of the Automation Master Validation Plan as needed. Ensure that the Computer System Validation on the project is conducted in a consistently high standard, within budget, and that objectives are met on time suiting the company's vision and objectives • Coordinate with various project workstreams including Automation, Automation System vendor(s), CSV, CQV, Utilities, Process Engineering, and others as needed. Attend regularly scheduled project status meetings as needed. • Complete Safety, Project Procedure, and Project Instruction training as required.
Project Management and Validation Consulting support for the Takeda EBM Project: Project Management • Manage Trackwise Change Records, Project BI, SPOT Project & Portfolio Management System • Managing demand & budget planning and follow-up on project and portfolio level • Develop and maintain project schedule – including coordination with project stakeholders and contributors to ensure project milestones are achieved • Facilitate project meetings, generate meeting minutes and mange project communication Validation • Develop Qualification/Commissioning Project Plan and Test Cases • Develop and participate in the Criticality and Risk Assessment • Review User Requirement Specification • Review Functional Design Specification(s) • Develop Requirements Traceability Matrix • Commissioning and Qualification protocol(s) development, execution and failure logging and resolution • Development of final summary reports
- MQWP data integrity workstream - define and document the Site approach to assessing all Site Good Manufacturing Practices (“GMP”) manufacturing systems (approximately 1600 items) against data integrity requirements, and complete all associated assessments - Define the Site approach to complying with Quality Requirements (“QR”) document, Global Standard and Process (“GSP”) documents and audit trail Standard Operating Procedure for all site GMP automation systems (including control systems and computer systems). Including: - Classification of Site GMP automation systems (approximately 300 systems) by type, using any or all of the following criteria: control system topology; computerized system vs. process automation system; Good Automated Manufacturing Practice (“GAMP”) 5 software classification; unix accounts vs. group accounts - Justify why the Pharmaceutical Quality System (“PQS”) requirements apply or don't apply for each type of automation system, and describe how Genentech complies with the applicable requirements. - Document the system classification and compliance justification in a quality approved document. - Identify remaining gaps that must be addressed by future projects Deliverables.