North Carolina Process Equipment
Resume:
George E. Berg, Jr.
** ******* ****. ******* ******* NC
*********@*****.***
SUMMARY OF EXPERIENCE
I have 25 years of experience in Bio-Pharm Engineering & Construction industry
PROFESSIONAL EXPERIENCE
Mulligan Property Services LLC (Dec 2019 – Present)
Owner
Managed complete operation of construction company
Custom horse barns and home renovations
Every project on time and or ahead of schedule and on budget
Regeneron (April 2013 – Nov 2019)
Manager of Facility Engineering Support
Manages area through subordinates.
Ensuring that there are no breakdowns or disruptions in the production processes.
Conducting regular inspection and maintenance of all the pharmaceutical equipment in the facility.
Ensuring that all safety norms and regulations are adhered to.
Oversees testing of the pharmaceutical equipment to ensure that the same is seamlessly working.
Planning maintenance and service activities in a way that the process of the production does not get hampered.
Ensuring that the process equipment is being used to full capacity and that production is optimum.
Ensure records are made of all service, maintenance, and refurbishing works carried out on the process equipment.
Plans and schedules maintenance repairs/modifications of facility and process equipment.
Oversees troubleshooting of process equipment problems and make required changes.
Ensure all areas of responsibility are in compliance with cGMP regulations.
BD – Becton Dickinson ( Feb 2008 to April 2013 ) North Carolina
Capital Project Manager / Facility Manager
First North Carolina employee hired to design/engineer/ and manage the construction of a state of the art aseptic sterile pharmaceutical fill finish facility in Wilson NC to be completed in 2010 and drug delivery in 2012.
Responsible for specifications of Fill/Finish Equipment using E-Beam Sterilization Techniques, Isolator Technology
and a closed system for compounding formulations. Assisted / Lead Groinger & Skan in a team effort to development a syringe filling piece(s) of equipment capable of filling 600 syringes a minute. Assisted / Lead 5 manufacturers of inspection and packaging equipment to develop a packaging line capable of packaging 600 units a minute.
Manage deliverables meetings in France with our French counterparts at our Pilot Plant
Writing Contracts and Scopes of work for bidding processes for all building equipment and construction services
Author SOP's, URS’s, FRS’s, Maintenance Procedures
Plant and Budgetary Planning for responsible areas
Managing day to day operations of plant for facility engineering, calibration and facility maintenance issues
Familiar with all plant utilities ( Chilled Water, Glycol Supply & Return, WFI, CIP/SIP, Pure Steam, Clean Steam, N2, Sterile Compressed Air, Boilers, Cooling Towers, Air Handlers, etc)
Manage Capital Projects
Wyeth Pharmaceuticals ( Feb 2005 to Feb 2008) Sanford North Carolina
Senior Bio-Pharm Construction Manager
Manage all aspects of Capital Projects assigned to me to assure timely completion for projects up to 300M
Safety of all persons involved in engineering and the construction and or maintenance activities
Preparing budgets for the upcoming year in regards to Capital Spending for the site
Manage and maintain all equipment upgrades and or modifications to central utilities ( Clean and Dirty)
Put teams together including plant engineering, plant maintenance, validation and purchasing to complete projects
FLUOR DANIEL (2001 to Feb 2005) North Carolina
Project Manager / Construction Engineer V Sanford, NC. Wyeth Project
Responsible for multiple contractors on site totaling $80M out of $300M
In charge of all aspects of High Purity process piping on project.
Responsible for updating as-built Orthographic and P & ID’s
Perform vender audits
Construction Budget Analysis for Cost Reporting
Analyze Earned Value (EV) Reports for Work-in Place (WIP) accuracy before issuance of project funds
Verify all AIA request for funds documents for accuracy
Coordination lead of Field Instruction Notices that change scope of project work for contractors
Coordination lead for Equipment Integration process as equipment arrives
DYNAMIC SYSTEMS (1999 to 2001) North Carolina
East Coast Regional Quality Control Manager
Specialized in Pharmaceutical protocol for installation of high purity piping systems and functionality of 15M projects
Insured all cGMP’s standards and BPE’s specs were adhered to
Handled all aspects of welder qualifications, procedures, and documentation
Acted as liaison between plant validation and DSI to achieve optimal production, validation, and commissioning
Developed company SOPs’ for Pharmaceutical process pipe.
Handled all employee HR responsibilities for QA/QC personnel on the East Coast
Assisted in Business Development / Marketing of East Coast Operations
Managed Fabrication Shop QA/QC functions
KINETICS, (1994 to 1999)
QA/QC Engineer
Specialized in high-purity piping systems in the pharmaceutical and semi-conductor industries
Responsible for administration and implementation of quality control program for the high-purity portion of multi-million dollar pharmaceutical projects
Responsible for borescopic examinations of all welds as well as all documentation for turnover to the FDA for validation.
CAD, detailed, and hand drafted isometric piping layouts
EDUCATION
Antelope Valley High School, Lancaster Ca
Facility Engineering Management Diploma 2010– North Carolina State University, Nc
Optimization in Manufacturing Diploma 2012– University of Kansas, Ks
PROFESSIONAL LICENSE/CERTIFICATES:
Pharmaceutical High Purity Level II welding Inspector (Visual)
ISPE Member (International Society of Pharmaceutical Engineering)
TRAINING
Experienced with all types of Pharmaceutical equipment, associated process, utilities piping and building equipment
10 Hour OSHA certificate training program
Autocad
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