We provide Commissioning, Qualification, Validation, Project Management, Calibration and Supplemental Staffing Services to our Pharmaceutical and Biotechnology industry customers.

Validation Manager for New Blood Plasma Fractionation Facility2014 ISPE Facility of the Year Award for Project ExecutionResponsible for the following project scope and activities.• Overall leadership, management and delivery of commissioning and validation scope of work for amajor capital expansion project and new manufacturing facility. Project scope includes automated indirect and direct impact utilities, CIP/SIP systems, production support equipment,centrifugation, filtration, buffer preparation and precipitation systems.• Commissioning and Validation Master Planning• Regulatory Submission Document Preparation• EU Inspection• Scope Definition and Control• Commissioning and Qualification Schedule Development• Budget Forecasting and Control• RFP Preparation, Review and Analysis• Resource Planning, Allocation and Management• Contingency and Mitigation Planning• Project Change Control• Quality System Audits and Remediation• CAPA Audits and Remediation• Protocol, Execution, Report Preparation, Review and Management

Project Management Support, Commissioning and Qualification – Responsible for thefollowing tasks, reporting to the Engineering and Operations Director.• Verification of the overall commissioning and qualification schedule, resourcerequirements and budgetary forecasts.• Project planning.• Creation of project tracking and reporting metrics for commissioning and qualificationactivities.• Challenge and update project URS, C&Q requirements and scope with respect toindustry guidance, standards and community practice.• Prepare and implement commissioning and qualification guidance and work instructionsfor IOQ component verification, drawing verification, screen navigation, design requirements verification use of factory acceptance test results, vendor tests,calibration, loop checks and deviation handling.• Process mapping and definition of material staging, component preparation,compounding, filling and inspection operations for use in SOP, Batch Record andprocess automation design, development and implementation.

Project Manager, Validation and Document ControlResponsible for the validation program development and implementation of the project validation master plan for a new inhalable pharmaceutical facility. Managed, prepared and reviewed commissioning and qualification protocols. Responsible for protocol execution, coordination with adjacent systems, equipment and implementation of corrective actions resulting from test failures. Created and maintained the integrated commissioning and qualification schedule and performance metrics. Schedule included the necessary deliverables, task durations, logic and resource loading to track and report project metrics necessary for the control of complex, fast track projects. Responsible for protocol execution, including coordination and implementation of the corrective measures necessary to address commissioning and qualification test failures, including coordination of vendor, engineering and construction resources.Project Scope Summary: • Process Air • Nitrogen• Clean Steam • High Purity Water• Solution Preparation Systems • Formulation Systems• UFDF • Cryogranulator• Lyophilizers (2), loading and unloading systems • Clean-in-place Systems• Indirect Impact Utilities (including HVAC) • Engineering Change Control• SOP Preparation

Project Information ManagerResponsible for the definition, collection and control of engineering and vendor data and documentation necessary for the lifecycle asset management of the utility, process and control systems associated with a new parenteral manufacturing facility. Responsible for the communication and management of data and documentation requirements for engineering, construction firms and equipment vendors. Definition of the data and documentation delivery schedule. Tracking, change control and metric reporting for data and document submissions. Coordination with commissioning and validation teams for the receipt and use of documentation necessary for protocol preparation and execution. Responsible for the preparation and verification of the commissioning and validation schedules and performance metrics.

Project Director – Responsible for leadership, coordination and management of a team of professionals to complete the commissioning and qualification (C&Q) requirements associated with the renovation of the primary insulin preparation and filling facility in the United States. Responsibilities included validation master plan preparation, implementation, integrated project schedule development, reporting tool development, and senior level management and coordination between engineering contractors, construction companies, contractors, vendors and C&Q staff. The project scope was comprised of more than 100 systems that included facility, utility systems, component preparation equipment, Lyophilization, manufacturing equipment, systems, environments and controls.Project teams and personnel from engineering, construction, commissioning and qualification were coordinated and managed successfully to renovate the facility, execute and post approved more than 400 commissioning, IQ, OQ and PQ protocols during a 4 month shut down period. The facility was returned to operation, according to the plan.