Peter Hong
Lansdale,PA
Summary
Focused Validation Specialist with experience in Pharmaceutical manufacturing validation. Insightful individual when testing systems to observe, analyze, measure, and calibrate processes and equipment to drive accuracy and quality. With a unique background with the ability to adapt and learn quickly.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Engineering Operations and Validation Specialist
GlaxoSmithKline King of Prussia, PA
02.2019 - Current
- Provide engineering and validation support for existing and new Sterile Manufacturing equipment and facilities, as well as Microbiology equipment and WREF-owned critical utility systems
- Responsible for providing engineering and validation support for planning and commissioning of new systems and for providing support for changes proposed to existing qualified equipment or systems by way of change control
- Responsible for providing support for engineering functions such as calibration, maintenance, and safety as it relates to the Sterile Pilot Plant
- Provide engineering and validation lifecycle support required to maintain the Sterile Manufacturing GMP process equipment, facility, and critical utilities in a compliant manner
- Activities include the development and execution of validation lifecycle documentation/test protocols, development and execution of engineering studies, development of processes and ways of working, troubleshooting of equipment and systems, participation in internal audits and inspections, and preparation of Standard Operating Procedures (SOPs)
- Generate Incursion Reports to assess and document impact on product quality and facility as a result of environmental excursion (e.g., temperature exceeds action alarm limit); provide updates related to Incursion Report status, provide metrics upon management request
- Provide technical support for Sterile Manufacturing GMP process equipment, facility, and critical utilities
- Interface with contracted facilities support staff and outside OEM equipment vendors to resolve issues, etc
- Provide technical support and guidance on computerized systems (e.g., PC, SCADA, PLC-based systems)
- Perform re-qualification for all qualified systems managed by Sterile Operations (i.e., Periodic Validation Review (PVR) and Validation Maintenance (VM)
- Perform routine temperature mapping studies on controlled environmental units (e.g., -20C Freezer)
- Develop and execute change controls for Sterile Manufacturing GMP process equipment, critical utilities, and facilities
- Develop and execute validation lifecycle documents for Sterile Manufacturing GMP process equipment, critical utilities, and facilities
- Develop and execute engineering studies for new technologies/equipment/processes (e.g., machinability of new components, critical zone smoke studies, temperature uniformity evaluations on controlled temperature units, etc.)
- Support quality deviations; provide input to the lead investigative team to determine the root cause of deviations and identify effective CAPA's to prevent future occurrences
- Participate in and/or support safety risk assessments on Sterile Manufacturing equipment and associated sterile manufacturing processes; participate in safety incident root cause investigations
- Collaborate with Management on process improvement initiatives to increase overall process efficiency; identify cost savings opportunities and opportunities to optimize existing processes
- Collaborate with the Sterile Team to deploy new technologies and initiatives that align with commercial manufacturing
- Participate in clinical Sterile Manufacturing operations, as requested.
- Documented the entire validation process, noting changes or alterations completed
CBRE Complimentary worker
GSK King of Prussia, PA
09.2013 - 02.2019
- Daily maintenance of multiple systems to ensure compliance with strict facilities standards.
- Conducts Impact analysis for upgrades/patch releases of surrounding systems.
- Daily Data analysis of key data points to ensure consistent compliance adherence to multiple facilities.
- Subject matter expert on system roadmap including leading change management meetings, system upgrades, and facility maintenance activities
- Create, manage, and update documentation regarding multiple systems
- Create and provide training to users
- Design, configure, and maintain new camera system
- Collaborate with multiple departments to install, and maintain new technologies
- Work with management to continually improve processes and workflows in order to increase facility uptime and improve productivity
Assistant Network Administrator
American Collectors Insurance
08.2011 - 07.2013
- Responsible to configure, install and administer network infrastructure and provide on call support for all mission critical systems
- Administrative responsibilities included updating and creating technical documentation
- Install and configure servers with RAID5 & 6 arrays and provide proactive maintenance
- Assist the Network Administrator and VP of Operations creating and updating IT policies to define acceptable usage policies of all technology assets in addition to assisting in project management of all network related projects
- Spearheaded the completion of major migration of backup and recovery systems
- Successfully installed and configured Fortigate firewalls to meet business needs
- Streamline network monitoring system used to notify staff regarding mission critical systems and applications
- Lead a project to resolve persistent network issues the organization had been experiencing prior to my arrival
- Reorganized shared folders structure for IT to create a more efficient way to store and save documentation.
Technology Support Specialist
Imhotep Institute Charter High School
08.2009 - 08.2011
- Provide support for all IT assets including networking hardware, servers, desktops, and laptops for over 500+ students and staff members in a challenging, ever changing environment
- Design, configure, install, and administer all technology for the entire campus and staff
- Designed and configured multiple lab environments with security measures to ensure the highest available systems uptime
- Maintain internet security using M86 firewalls
- Create, update, and maintain images for company using Ghost/Acronis software
- Provide support for all Servers, including upgrades, daily maintenance, backup and recovery administration
- Perform maintenance on all printers, faxes, and copiers
Production Support Analyst
GSI Commerce Inc
11.2007 - 08.2009
- Position entailed first level production systems support and analysis while providing timely updates to upper level support teams as well and management
- Monitor and maintain all incident reports to provide training and used by management to analyze potential trends
- Perform first level diagnosis and triage to the appropriate departments for higher level support
- Responsible for change management notification to the business and affected users
- Created and implemented protocol for high level, client facing issues
- Daily operational reporting of Email Correspondence, Priority Event, and PS Ticket activity
- Facilitation of internal customer and resource communication via the various TIS Ticketing Systems and PM Office
Education
New Horizons Computer Learning Center
King of Prussia, PA2005
Skills
- Technical Expertise
- Operation Systems: Windows 9X, XP, Vista, 7, Windows Server 2000-2008R2
- Hardware: WatchGuard, Fortigate, M86 firewalls, HP Procurve, 3Com & Netgear
- Software: Exchange 2003 & 2007, VMWare, Hyper V, MS Office Suites, Pervasive SQL10, Symantec Backup Exec 2010 & 2012, Symantec Endpoint Protection 12, Norton, Acronis Imaging, Ghost Imaging, McAfee, VNC Viewer, PC Anywhere, Double-Take, Host Monitor
- Network/Protocols: LAN/WAN, TCP/IP, WINS, DNS, DHCP, POP3, SMTP, FTP
- Telnet, PPTP & SSL VPN
Accomplishments
- Certifications: CompTIA A+, Network +, MCP, MCSA
Certification
Certified in CompTIA A +, Network +, MCP, MCSA
Timeline
Engineering Operations and Validation Specialist
GlaxoSmithKline King of Prussia, PA
02.2019 - Current
CBRE Complimentary worker
GSK King of Prussia, PA
09.2013 - 02.2019
Assistant Network Administrator
American Collectors Insurance
08.2011 - 07.2013
Technology Support Specialist
Imhotep Institute Charter High School
08.2009 - 08.2011
Production Support Analyst
GSI Commerce Inc
11.2007 - 08.2009
New Horizons Computer Learning Center
Certified in CompTIA A +, Network +, MCP, MCSA
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