Brett Luongo Email & Phone Number

Boston, Massachusetts, United States

Waltham, Massachusetts, United States

Plainville, Massachusetts, United States

• Contamination control/sterility assurance SME.• Author site contamination control strategy and supporting FMEA.• Drove the successful qualification of 100,000 ft² GMP environment and associated critical utilities for viral vector manufacturing.• Execute Annex 1 gap assessment for the manufacture of sterile medicinal products and support the CAPA process to close identified gaps.• Lead cross functional risk assessments for the design and continuous improvement of manufacturing processes, facility design, material/personnel movement, cross-contamination, microbial risk reduction policies etc.• Provide guidance on the qualification site isolators regarding sterility, specifically risk-based analysis of interventions and first air concerns. • Design and implement the sites APS strategy, defining critical parameters and documenting the risk-based justification for worst cases. • Continually reviewed US, EU, and ICH guidance to support compliant site procedures as well as support internal and external audits. • Provide microbial expertise to support QRM and change management.

Waltham, Massachusetts, United States

• Investigate alert/action conditions by conducting root cause analysis.• Designing and executing environmental qualifications (IQ/OQ/PQ) for controlled environments as well as author PQ / Routine EM trend reports.• Manage internal EM analysts, schedule attainment, performance review, project coordination.• Analyze internal environmental monitoring data and update alert/action limits as needed.• Act as SME for EM across global network.• Execute gap assessments for internal EM program.

Marlborough, Ma

• Subject matter expert responsible for performing risk assessments and developing environmental surveillance strategies in accordance with ISO 14644-1/2: 2015• Designing and executing environmental qualifications (IQ/OQ/PQ) for controlled environments. • Consult with clients to provide appropriate guidance on sampling criteria, testing parameters and control measures.• Analyze internal environmental monitoring data and update alert/action limits as needed.• Conduct root cause analysis for OOT results with regard to internal environmental monitoring and work within the quality management system to close out associated events. • Design environmental sample plans within VISIO regularly updating maps to reflect changes in intended use, layout, personnel occupancy and sample strategy. • Deliver technical expertise to account management and business development in order to scope out new projects and write the associated proposals.• Expert in the interpretation and practical application of environmental control best practices as stated across industry guidance (ISO, ISPE, WHO, AAMI, PDA).Cambrex acquired Avista Pharma Solutions in January 2019

Marlborough, Ma

Cambrex acquired Avista Pharma Solutions in January 2019

Taunton, Ma

• Oversee the daily functions of the PCS microbiological laboratory.• Conduct the testing and incubation of biological indicators to ensure the sterility of the medical device.• Perform calibrations on all inventoried laboratory equipment as well as numerous controlled aspects of the sterilization process. • Develop and execute site specific environmental monitoring programs for clean rooms and manufacturing facilities. • Complete the enumeration and microbial characterization for populations of viable microorganisms on or in a medical device, component, or package.• Institute, review, and maintain procedures, protocols, and systems required to meet both FDA and ISO standards for the sterilization of medical devices.• Work with other divisions of the PCS management team to evaluate and process document change requests.• Interpret and carry out client specific protocols for the validation or requalification of the ethylene oxide gas sterilization of medical devices.

Weymouth, Ma

• Ran inorganic digestions and extractions on soils, liquids (waters), and irregular materials.• Tested the quality of air samples for the presence and quantity of contaminants.• Performed toxicity leaching procedures on numerous materials from plastics to steel girders.• Responsible for all laboratory housekeeping as well as the use of the acid bath for the decontamination of glassware.• Review and update relevant procedures for the implementation of best practices.

Somerville, Ma

• Work in teams to perform lab pack services including chemical segregation, packing, and disposal. • Perform chemical inventories, audits, and inspections of facilities and laboratories.• Assist management in developing top accounts and devising standard operating procedures.• Obtain knowledge of technical, customer service, and business components of environmental services.• Learn and work with, computerized waste tracking systems.

Bachelor Of Science, Biology, General

Activities and Societies: • Sacred Heart University Dean’s List: Fall 2006, Spring 2007, Fall 2007 • National Collegiate Honor Society.

Master'S Degree, Environmnetal Science & Policy

Activities and Societies: • Clark University Graduate Student Scholarship 2010-2012 • Clark U. Honor Society 2010-2012 • Clark U..