Experience

Emergent BioSolutions

• United States
• Biotechnology Research
• 700 & Above Employee

• Manager - Commissioning, Qualification and Validation

  • Apr 2023 - Present

  Canton, Massachusetts, United States o Oversee day-to-day activities and manage the commissioning and qualification program for GxP production equipment, laboratory equipment, and utility systems at the site. o Provide leadership and guidance to the team and ensure personnel development. o Lead cross-functional efforts in qualification programs, impact assessments, deviations, CAPAs, and change controls. o Continuously improve department processes and assist other areas as needed. o Ensure consistent application of CQV… Show more o Oversee day-to-day activities and manage the commissioning and qualification program for GxP production equipment, laboratory equipment, and utility systems at the site. o Provide leadership and guidance to the team and ensure personnel development. o Lead cross-functional efforts in qualification programs, impact assessments, deviations, CAPAs, and change controls. o Continuously improve department processes and assist other areas as needed. o Ensure consistent application of CQV procedures and testing templates for site projects (both OPEX and CAPEX). o Draft, review, and approve protocols and functional testing documentation. o Supervise and execute protocol activities and final reports. o Provide technical support on all stakeholder projects as required.

• Interim Manager - Commissioning, Qualification and Validation

  • Nov 2022 - Apr 2023

  Canton, Massachusetts, United States

• Senior Validation Engineer

  • Jun 2019 - Apr 2023

  Canton, Massachusetts, United States o Lead temperature control unit qualifications and capital projects. o Manage quality management activities, including deviations, CAPAs, change controls, and effectiveness checks.

• Engineer, Commissioning and Qualification/Validation

  • Jul 2018 - Jun 2019

  Canton, Massachusetts, United States o Commissioned and qualified GxP production equipment and laboratory equipment. o Developed and executed qualification protocols (IQ, OQ, PQ). o Conducted temperature mapping and CIP/SIP activities.



DPS Group Global

• Ireland
• Architecture and Planning
• 700 & Above Employee

• Lead Validation Engineer

  • Dec 2017 - Jul 2018

  Greater Boston Area o Lead validation engineer for the suite expansion project, managing commissioning and qualification tasks. o Hands on experience with FAT, SAT, and IO/OQ/PQ activities. Scope of Work: CIP Skid Parts Washer Bioreactors Media Vessels Transfer Lines/Utilities



Hyde Engineering + Consulting

• United States
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Validation Engineer

  • Nov 2015 - Nov 2017

  Greater Boston Area -> ClP Cycle Development Project - Validation Lead Leading, managing, coordinating, and executing cycle development tasks. This includes confirmation of hydraulics of the cleaning circuits, determination and confirmation of CIP parameters for achieving the required reduction of process soil and cleaning agent residues as well as reducing microbial levels to acceptable limits from equipment. Seed Bioreactor Production Bioreactors Media Feed Tanks Harvest… Show more -> ClP Cycle Development Project - Validation Lead Leading, managing, coordinating, and executing cycle development tasks. This includes confirmation of hydraulics of the cleaning circuits, determination and confirmation of CIP parameters for achieving the required reduction of process soil and cleaning agent residues as well as reducing microbial levels to acceptable limits from equipment. Seed Bioreactor Production Bioreactors Media Feed Tanks Harvest Tanks Media Headers Harvest Headers -> Cleaning Validation Project Supporting cleaning cycle development and cleaning validation project Generating protocols, coordinating execution, and taking rinse and swab samples for cleaning validation studies like performance qualification, cleaning verification, clean hold, and dirty hold study. Investigate causes for discrepancies/deviations and provide corrective and preventive actions to be implemented. Production Bioreactor Media Feed Vessel Harvest Vessel Manufacturing Skid Chromatography Skid Buffer Transfer Lines Portable Vessels (50L/100L/200L) Hoses Part Washer -> Commissioning Projects Lead the assigned system tasks, and manage project timeline and deliverables. Generate, review, revise, and execute commissioning documents. Review URS, FAT, SAT, and other TOP documents. Buffer Prep Tanks Buffer Storage Tanks Buffer Transfer Panel Purified Water Storage Tank WFI Storage and Distribution System Utilities – N2, CO2 and Instrument Air Cold Room Show less



Regeneron

• United States
• Biotechnology
• 700 & Above Employee

• Consultant (Intracom LLC - Validation Specialist and Rai Consulting - Validation Contractor)

  • Apr 2013 - Nov 2015

  Rensselaer -> Lead and Manage Temperature Mapping Program -> Lead and Manage Capital Projects for new suite as well as suite expansion -Equipment Qualification Bioreactor Media Vessel Centrifuge Buffer Vessels Purification Vessels - Utility Qualifications Oxygen Carbon Dioxide Nitrogen Pharmaceutical Air WFI -> General Validation Support Generate, execute, and review validation documentation and associated data using eDoc… Show more -> Lead and Manage Temperature Mapping Program -> Lead and Manage Capital Projects for new suite as well as suite expansion -Equipment Qualification Bioreactor Media Vessel Centrifuge Buffer Vessels Purification Vessels - Utility Qualifications Oxygen Carbon Dioxide Nitrogen Pharmaceutical Air WFI -> General Validation Support Generate, execute, and review validation documentation and associated data using eDoc and Please Review – document management system to create review, edit, and share documents. Ensure conformance of data and documentation to regulations, SOPs, specifications, and other applicable acceptance criteria. Prepare equipment/systems for qualification studies and execute according to approved protocols and SOPs. Analyze the results of testing and determine the acceptability of results against pre-determined criteria. Investigate and troubleshoot problems that occur and determine solutions or recommendations for changes and/or improvements. -> Clean In Place (CIP) Sampling (TOC Swabs, Bio-burden Swabs, and Rinse Sampling) LIMS – software for laboratory management, to submit, track and review results of samples -> Cleaning Hold and Dirty Hold studies ->Steam Sanitization Qualification (SIP) Handling Biological Indicators (BIs) Kaye Validator TCs – Calibrations Show less



Genzyme

• Validation Contractor (Intracom LLC)

  • Sep 2012 - Apr 2013

  Greater Boston Area o Generation of cGMP documentation such as Protocols (IQ, OQ, PQ, and Commissioning), Final Reports, Deviations, and SOPs o Performed Document Verification, Calibration, Utility Verification, Drawing Walk-Down, Thermal Mapping, and Engineering Studies using Kaye Validator o Commissioning, Qualification, and Validation of equipment including Refrigerators, Freezers, Incubators, and Bio Safety Cabinets within the Quality Control Laboratory



Stevens Institute of Technology

• United States
• Higher Education
• 700 & Above Employee

• Graduate Assistant

  • Jun 2011 - May 2012

  Hoboken • Perform a variety of administrative tasks including preparation of study materials, data entry, and collating marketing materials and presentations. • Provide assistance with event planning. • Supervise a computer laboratory. • Document all changes to the systems.



Stevens Pharmaceutical Research Center - Acadamic Project

• Validation Projects - Engineer - Student

  • Aug 2010 - May 2012

  Hoboken, New Jersey o Performed process/product development studies at the lab, and learned about Qualification (IQ, OQ. PQ) and Validation. o Written/Modified Technical documents like SOPs, IQ, OQ, PQ Validation Protocol, VMP, and Reports. o Experience with Minitab and Electronic document management systems (M-files). o Worked with/on Statistical process control tools, like DOE, Process Capabilities, and Gage R & R. o Experience with temperature mapping. o Experience with Commissioning, URS, FAT… Show more o Performed process/product development studies at the lab, and learned about Qualification (IQ, OQ. PQ) and Validation. o Written/Modified Technical documents like SOPs, IQ, OQ, PQ Validation Protocol, VMP, and Reports. o Experience with Minitab and Electronic document management systems (M-files). o Worked with/on Statistical process control tools, like DOE, Process Capabilities, and Gage R & R. o Experience with temperature mapping. o Experience with Commissioning, URS, FAT, SAT, and RTM. o Worked with/on GMP Environment requirements, SOP, HPLC, TOC, lab safety, deviation investigation by FMEA, and Swab Sampling. Show less



Blue Cross Laboratories Ltd.

• India
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Professional Sales Officer

  • Sep 2009 - Mar 2010

  o Conducted market analysis, product evaluations, and market surveys to inform sales strategies and tactics.