A highly motivated self-starter possessing in-depth knowledge of cGMP/FDA regulations specializing in process and computerized system validation. Demonstrated management and technical abilities in the validation of both sterile and non-sterile facilities. Qualified process equipment/systems for both liquid and solid dosage for manufacturing and packaging operations. Supervised and managed validation groups through to project completion. Provided technical guidance for a variety of equipment and computerized systems.

Senior Validation Engineer @ From 2000 to Present (15 years) Avex Validation Consulting Services @ Responsible for the development and execution of Qualification Protocols and Final Summary Reports in accordance to design documentation requirements such as Validation Plans, URS, FRS and SRS to Qualify and implement the use of the: • Liquid Manufacturing Process Automation Control System • HVAC / BMS Control System • SCADA Based Process Mixing Station Control System • High Speed Labeling/ Cartoning/ Automated Vision/ Inspection system for Vial Packaging • SCADA application FactoryTalk SE system providing control, alarm status monitoring, alarm logging, and acknowledgement management functionality From 2008 to Present (7 years) Avex Validation Consulting Services @ Generated and executed Computerized System Validation SDLC documents and protocols. Prepared SDLC protocols and documentation for Quality Assurance and sterile air handling systems including Validation Plan, User Requirements Specification, System Specification, Technical Design, Commissioning, Installation Qualification, Operational Qualification, Performance Qualification, Requirements Traceability Matrix, Execution Deviations, and Final Summary Report. Qualified the upgrade of the Building Automation System front-end from Siemens APOGEE Insight v3.3 to Insight v3.5.1 with the Compliance Support Option that is compliant with 21CFR Part 11. Validated the Insight v3.5.1 system to be utilized with Terminal Services (Citrix). Qualified the upgrade of the Building Automation System front-end from Honeywell Enterprise Building Integrator (EBI) release 310 and 410. Audited and performed retrospective validation on legacy manufacturing and packaging equipment to comply with FDA regulations. Authored and executed DQ, IQ, OQ, and PQ protocols for sterile packaging equipment. From 2000 to Present (15 years) Avex Validation Consulting Services @ Performing Validation Consulting Services for the Facilities/ Engineering Department. From 2013 to Present (2 years) MDC Consultants @ Performed a comprehensive review of drawings for the sterile air handler system. Innovated a new tagging convention to eliminate equipment identification discrepancies. Conducted a criticality assessment to determine an instrument’s impact, direct or indirect, on a process. Established User Requirements Specification for manufacturing equipment in accordance with International Society for Pharmaceutical Engineering (ISPE) guidelines. Generated Design Specifications and Requirement Traceability Matrix to ensure User Requirements Specifications were met. From 2011 to 2011 (less than a year) MDC Consultants @ Responsible for the development and execution of Qualification Protocols and Final Summary Reports in accordance to design documentation requirements such as Validation Master Plans, URS, FRS and SRS to Qualify and implement the use of process manufacturing and laboratory equipment including; Centrifuges, Incubators, Rotary Pumps, Cold Boxes, Refrigerators, Freezers, Dust Collection Systems and Stir Plates. From 2009 to 2011 (2 years) Validation Engineer @ Responsible for the generation/execution of IOP/Q, Modification validation and CSV protocols for Quality Control systems, solid/liquid dose manufacturing, packaging systems and QC laboratory. Performed off-site Factory Acceptance Testing for manufacturing and packaging equipment. Project manager for the assessment and revision of Engineering, Manufacturing and Packaging SOPs to current cGMP/FDA regulations as well as their computerized systems to meet 21 CFR part 11. From 1999 to 2000 (1 year) Environmental Engineer/Senior Architectural Draftsman @ Managed facility reporting and permits (air, wastewater, and solid waste) in compliance with EPA, OSHA, and DEP requirements. Handled and disposed of hazardous material in compliance with OSHA, EPA, and DEP requirements. Designed and revised AutoCAD blueprints for pharmaceutical plant operations including HVAC, P&ID, and complete plant layout. Supervised contractors on renovation projects and maintenance. From 1996 to 1999 (3 years)

Bachelor of Engineering (BEng), Environmental Engineering @ Stevens Institute of Technology Kevin Serafin is skilled in: Validation, Computer System Validation, Building Management Systems, Building Automation, HVAC Controls, Change Control, GMP, GxP, 21 CFR Part 11, GAMP, GLP, Quality Assurance, Quality Control