CHAD MEREWETHERCommissioning & Qualification Specialist

OVERVIEWChad Merewether has been providing PCI clients with high valued, quality technical services since 2014. As a CQ Specialist with PCI, Mr. Merewether evaluates existing operations, collaborates with the client to provide effective solutions, and develops a client-customized plan to achieve consistent measurable results. His educational background in biomedical engineering, expertise, and specialized resources enable him to support client commissioning and qualification programs from start to finish and help him quickly identify engineering specifications, fit for purpose, and system optimization that can save clients time and money.

Mr. Merewether background includes calibration services in a metrology lab on laboratory instrumentation and mechanical equipment. He also provides troubleshooting support and root cause analysis as needed. Mr. Merewether participates in PCI’s annual Good Manufacturing Practices and Quality Assurance training. Mr. Merewether has extensive installation, troubleshooting, calibration, validation, and systems programming experience.

Prior to joining PCI, Mr. Merewether worked as an Electronics Tech/Calibrator for the US Marine Corps from 1998 to 2002 and as a Sub Contractor/Project Manager for various commercial and residential construction companies from 2002 to 2009. From 2009 to 2014, Mr. Merewether earned his biomedical engineering degree.

PCI EXPERIENCEAs a CQ Specialist with PCI, Mr. Merewether provides services to various clients, projects, and ongoing service accounts, including:

Commissioning, Qualification, Calibration, and Validation tests on manufacturing process equipment and instruments.

Author protocols and initiate controlled documentation in support of CQV projects. Provide project planning, management, execution, and follow up. Review equipment specifications, manuals, and develops an understanding of how an instrument

works; tests equipment to accurately verify it is working as intended. Investigate failures and deviations, creates reports. Spare parts review, fit for purpose, and analysis. Review design specs to establish fit-for-purpose for systems. Review engineering drawings for accuracy. Perform system walk-downs, and change control of processes. Initiate and resolve client Corrective and Preventive Actions (CAPAs). Investigate deviations and failures. Provide summary and analyses reports Create and maintain job plans, maintenance and PMs

One of Mr. Merewether’s client projects involves the identification and designation of equipment hierarchy in a large pharmaceutical manufacturing facility’s global CMMS (INFOR-EAM), spanning across all facilities supported by Worldwide Real Estate and Facilities organization. The purpose of this project is to improve current equipment hierarchy’s to help facilitate the requirements of Maintenance Operations Engineering and to meet the Global Engineering Standard GES 103.

Mr. Merewether’s key activities through this project have included the following: Defining “Level-1” assets for adoption across all WREF sites.

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CHAD MEREWETHERCommissioning & Qualification Specialist

Extraction of data from EAM/Datastream into data collection files formatted to capture hierarchy structure changes.

Walk down of existing facilities/systems and examination of current piping and instrumentation diagrams to verify location data and parent/child relationships.

Cleansing of impact/criticalities in line with customer validation assessments and project business rules. Execute data migration protocols to include the administration of data verification test cases.

PREVIOUS POSITIONS HELDContractor of Engineering Projects, Self Employed; 2009-2014

Designed and implemented graphical user interface for neuroscience experimentation with a team Design and construct basic EEG and acquire signal from human subject Design and construct a line-following robot with a team Design and construct a hovercraft with a team Completed SolidWorks model of a water wall design including exploded views and bill of materials

Contractor/Project Manager, Merendino Construction, Clayton NC; 2007-2008 Project management of custom built homes Designed and changed plans, pulled permits for additions, remodels, tile flooring and enclosures

Calibrations Platoon, ELMACO, 2nd Maint. Batt., 2nd FSSG, United States Marine Corp; 2000-2002Calibrator for 2nd MEF

Calibration of electrical and mechanical equipment: Electrical: frequency generators, spectrum analyzers, digital oscilloscopes Mechanical: Scales, pressure gauges, torque wrenches

Radio Platoon, ELMACO, 2nd Maint. Batt., 2nd FSSG, United States Marine Corp; 1998-2000Electronics Tech for 2nd MEF

Communications testing and repair: Diagnostics and repair of SINCGARS radio units Setup and test wired and radio communication systems

EDUCATION/CERTIFICATIONS Bachelor of Science Degree in Biomedical Engineering, East Carolina University, Greenville, NC Graduate of US Marine Corps MCCES School of Electronic Repair and Calibrations

PROFESSIONAL AFFILIATIONS Member of International Society of Pharmaceutical Engineering (ISPE) Young Professionals Member of the Order Of The Engineer

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