Managed the requalification program for controlled temperature units (CTUs): refrigerators, freezers, incubators, environmental rooms, and warehouses. Key responsibilities were the governance of program documentation, data pack pre & post approval, the scheduling and close-out of work orders, deviation investigations, and the management of contract personnel. In 2024, approximately 150 CTUs were successfully requalified.Managed the revalidation program for biotechnology manufacturing equipment: fermenters, centrifuges, chromatography columns, virus removal skids, UF/DF skids, CIP skids, COP skids, clean utility systems, HVAC systems, etc. Key responsibilities were the governance of program documentation, the scheduling and close-out of work orders, deviation investigations, and the management of personnel. In 2024, approximately 240 individual systems were revalidated.Methodology lead for clean utilities qualifications: Incorporated dynamic smoke studies into curtained HEPA area (CHA) requalifications. Overhauled the HVAC qualification program. Overhauled the gas qualification program.Managed the Computer System Validation (CSV) for the qualification of Ellab Val Suite thermal process system, including templates for moist heat sterilization. SDLC deliverables included: Project Validation Plan, User Requirements Specification, Functional Specification, Configuration Specification, Electronic Records / Electronic Signature Assessment, Data Integrity Assessment, Computer System Risk Assessment, Traceability Matrix, Operational SOPs & FORMs, ADMIN SOP, PQ Protocol, and all associated Summary Reports. Managed Trackwise Change Controls & CAPAs for simple and complex projects (e.g. > 200 individual action items). Member of the Validation Governance Steering Committee. Represented areas of responsibilities in regulatory inspections, corporate audits, and internal audits.

Define, develop and implement Engineering, Commissioning & Qualification (C&Q) Best Practices through the application of ISPE, ASTM and GAMP methodologies, ensuring compliance to FDA regulatory and corporate quality directives.Subject matter expert in the areas of Formulation, Filling, Inspection, and Packaging of parenteral products in vial and single-use syringe dosage forms.Manage 2 - 8 engineers and/or contract C&Q personnel in the generation of Engineering C&Q deliverables for CAPEX projects--Specifications: User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Hardware Design Specifications (HDS), and Software Design Specifications (SDS).-Risk Assessments: System Level Impact Assessments (SLIA), Functional and Component Criticality Assessments (FCCA), Hazard and Operability Analysis (HAZOP), Failure Mode and Effects Analysis (FMEA), and Fault Tree Analysis (FTA).-Commissioning Protocols: Factory Acceptance Test (FAT) Protocols, Site Acceptance Test (SAT) Protocols, Non Critical Test Protocols (NCTP), Deviation Management (Principle Investigator), and Summary Reports.-Qualification Protocols: Installation and Operational Qualification (IOQ) Protocols, Critical Test Protocols (CTP), Performance Qualification (PQ) Protocols, Deviation Management (Principle Investigator), and Summary Reports.-Project Management: Project Commissioning and Qualification Plans, C&Q Estimates, Vendor Selection, Project Timelines (small projects), Deliverables Dash Boards, Site Change Management, Engineering Change Management, Continuous Improvements, and Lessons Learned.Supervise all C&Q execution activities and report directly to Engineering management. As required, recommend corrective actions and facilitate follow-up.