James Overton

Wilson, NC *****

252-***-****

adcfo6@r.postjobfree.com

Result/Service solution oriented professional with 36 years of progressive experience in reliability, maintenance and metrology. I am a team player that handles tasks with accuracy and efficiency. I have a track record of achieving exceptional results in Maintenance, Data Management, Quality Systems, and Calibration Programs.

SOFT SKILLS

Integrity, Dependability, Effective Communication, Teamwork, Creativity, Problem-Solving, Critical Thinking, Adaptability, Organization, Willingness to Learn, and Empathy

HARD SKILLS

Reliability, Plant Maintenance, Calibration, Proactive Maintenance, Preventive Maintenance, Designing Plant Reliability and Maintenance Programs, Equipment Criticality Assessment, Equipment Hierarchy/Registry, Auditing PSM Processes for Compliance, Root Cause Analysis, Maintenance Program Implementation, Training and Coaching, Project Management, Team Work, Power User Computer Skills (MS Office, Teams, Outlook, Word, Excel, Access, PowerPoint), and SAP CMMS.

PROFESSIONAL WORK EXPERIENCE

WorleyParsons/Advisian (Fayetteville, NC)

Plant Maintenance and Reliability Practitioner (contract fulfilled) Aug 2019 – Jan 2020

Performed criticality analysis of newly constructed system and sub-components to assist a chemical manufacturing client meet and exceed regulatory requirements.

Provided input that anticipated reliability-related, and non-reliability-related risks that could adversely impact plant operation.

Assisted Project Lead in systematically defining, designing, developing, monitoring and refining a value-added Asset Maintenance Work Plan that included:

oContacting Manufacturers and vendors to collect IOM Manuals.

oDeveloping recommended spare parts list.

oEffective utilization of predictive and other non-destructive testing methodologies designed to identify and isolate inherent reliability problems.

oGenerating Equipment Functions, Functional Failures, Failure Modes and Failure Effects.

oGenerating Protective Device List and PSM Critical Lists.

oConducting Root Cause Failure Analysis to help prevent failures.

North Carolina State University_Biomanufacturing Education & Training Center (BTEC) (Raleigh, NC)

Maintenance Engineer Dec 2017 – Aug 2019

Established a GMP compliant Maintenance/Calibration Program consisting of M&TE procurement, developed procedures, organized files, performed in-house maintenance/calibrations and developed/maintained Computerized Maintenance Management Software (CMMS) (inventoried all systems/equipment/instruments, and devices, generated work orders, tracking, planning, scheduling, etc.) database, and vendor management.

Coordinated and performed maintenance/calibrations on facility systems and equipment, including air compressors, reverse osmosis water systems, bioreactors and autoclaves.

Sequence, Inc. (Morrisville, NC) Jul 2015 – Aug 2017

Senior Consultant, Technical Manager (from Feb 2017 – August 2017)

Performed maintenance/calibrations as needed, maintained compliance, maintained maintenance (calibration) schedule, monitored maintenance/calibration performance.

Supervised and trained technicians, managed equipment maintenance and calibrations.

Developed and validated new or modified calibration methods as needed.

Evaluated maintenance/calibration results and data, and preparing and overseeing customer site maintenance/calibrations.

Senior (Metrology) Consultant (Morrisville, NC) (from Mar 2016 – Feb 2017)

Located and qualified calibration service provider at an annual cost savings of $15K+.

Responsible for inventory of reference measurement & test equipment and working standards. Updated and maintained asset filing system and database, ensuring all assets were calibrated as scheduled.

Vendor liaison, SOP revisions, CAPAs, labels, manuals, quotes, rentals, estimated costs for ISO/IEC 17025 compliance.

Assisted in the development of a compliant ISO/IEC 17025 calibration program for calibrating pipettes.

Senior Consultant, Laboratory Asset Coordinator (from Jul 2015 – Mar 2016)

Developed compliant Metrology Program for validation relevant assets to prepare client for FDA Compliance.

oThe program involved inventory database, filing system, SOPs & work instructions calibration due notices.

oThe program SOPs were for vendor process & expectations, training requirements and matrix, calibration certificate compliance checklist, emergency contact and ancillary component placards.

oAlso included in the program were installation and start-up checklists, specifying and procuring assets, decommissioning or retiring assets, out of tolerance investigations, etc.

Quality Metrology Consulting Services (Wilson, NC) Apr 2014 - Jul 2015

Senior Consultant & Owner

I started Quality Metrology Consulting Services (QMCS) first from my passion for the science of measurement (Metrology) and second, from the quality of work Grandfather and Father instilled in me.

Authored (for highly regulated industries) a quality manual for customers, quality system procedures, training program, operation, and preventive maintenance/calibration procedures to prepare them for their ISO/IEC 17025 Accreditation.

Applied Calibration Services, LLC (Wilson, NC) Nov 2011 - Mar 2014

Manager of Quality, Deputy Manager of Technical Operations, Trainer & Safety Officer

Instrumental in establishing a Metrology Laboratory from initial conception through to the ISO/IEC 17025 Accreditation Process for parent company of Pharma Matrix, Inc.

oAuthored an ISO/IEC 17025 Compliant Quality Manual, associated Quality System Procedures and other applicable procedures (maintenance/calibration, operation, safety, training, etc.) and forms.

oSpecified and procured the necessary NIST Traceable Reference (measurement) Standards and Reference Material Standards to conduct laboratory and field calibrations for parameters such as: chemical, dimensional, electrical, mechanical, thermodynamics, time and frequency.

Conducted internal audits, liaison for external audits, recalls, generated maintenance/calibration due notices, maintained corrective and preventive actions, addressed client complaints.

Developed internal training program.

Pharma Matrix, Inc. (Wilson, NC) Oct 2011 - Nov 2011

Senior Validation Specialist

Executed Installation, Operational, and Performance Qualification Protocols for incubators and a minus 70 Degree C Walk-In Freezer.

oBecame parent company of Applied Calibration Services, LLC.

KBI Biopharma, Inc. (Durham, NC) Oct 2010 - Feb2011

Metrology Manager

Managed the effective and efficient operations of the organization’s Maintenance/Metrology Program.

Brought HPLC System preventive maintenance and calibrations in-house at a significant annual cost savings of greater than $80K.

Gilead Sciences, Inc. (Durham, NC) Jun 2004 - Oct 2010

Senior Research Associate, Senior Analytical Laboratory Metrologist

Facilitated the Analytical Metrology Program for the Bio-Analytical Laboratory Operations Group for analytical laboratory instrumentation (balances, centrifuges, controlled storage units, HPLCs, pipettes, etc.).

Maintained compliance by authoring SOPs, performed preventive maintenance and maintained spare parts databases/inventories. Executed IQ, OQ and PQs, initiated change requests, troubleshot and repaired as necessary.

EDUCATION

American Society of Quality

Certified Calibration Technician

2013

A.A., Business Administration

Strayer University

2007

United States Navy

Instrumentman (Calibration)

Class “A” School

(SIMA Pearl Harbor and Mediterranean Deployment)

1990

VOLUNTEERING

Boy Scouts of America – Den Leader (Volunteer)

Rolesville Parks and Recreation – Baseball Coach (Volunteer)

Peace Church – St. John’s Homeless Meals Food Kitchen (Volunteer)

Peace Church – Helping Hands Ministry (Volunteer)

Peace Church - Upward Sports Program – Basketball Coach (Volunteer)

Wilson County Youth Athletic Association – Baseball Coach (Volunteer)

Wilson Parks and Recreation – Baseball, Football, and Soccer Coach (Volunteer)

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