Operations / Special Projects Manager
Resume:
WILLIAM F. KIERNAN
Levitttown, Pa 19054
*********@*****.***
PROFESSIONAL EXPERIENCE:
**** – 5/2010 Assistant Operations Manager/Computer Specialist
Site closed as result of merger
Fort Dodge Animal Health/Wyeth Pharmaceutical
Animal Health Research Analytical
Princeton, NJ 866-***-****
Assistant Operations/Special Projects Manager
Special Project/ Site Closure 12/2009 – 5/2010
• Provided project management to facilitate the shut-down of site operations and transition of functions to new facilities as a result of corporate merger.
• Managed the team for the end phase of migration operations in Kalamazoo, MI
• Developed detailed project plans, coordinated and monitored project activities and reported weekly status to senior management
• Managed inventory audits and equipment sales and transfers
• Transition of knowledge of software, data, standard operating practices
Management of Operations – 7/2002 – 11/2009
• Responsible for direct day to day management of lab operations
• Supervision of contractors onsite to ensure safety and security
• User acceptance Testing oversight and validation IQ/OQ/PQ
• Held principal oversight responsibility for $5M budget
Provided functional performance oversight for development, test and configuration management
• Write, manage and perform Computer System Validations (CSV) following 21CFR part 11, GAMP4 and established methods, standard operating procedures, Good Manufacturing Practices (GMP) and other appropriate procedures for CDAS and the laboratory IT infrastructure.
• Project management for the installation and validation of the CDAS servers.
• Plan, conduct, interpret work on computer-related problems and change controls.
• Negotiate and secure vendor contracts for services on laboratory equipment to ensure cost effectiveness and savings for the company.
• Organize and perform validations following established methods, standard operating procedures, Good Manufacturing Practices (GMP) and other appropriate procedures. Plan, conduct, interpret work on computer-related problems and change controls.
• Modify computer programs and systems in response to changing situations. Develop new computer programs or systems using established technology.
• Ensure the performance and compliance of operating systems and laboratory computer systems, perform standard repairs when necessary. Maintain lab equipment such as HP 1100, Refrigerator / Freezer, Carl Fischer, ovens.
• Develop and implement plans to maintain GLP/GMP compliance, manage the computerized GLP samples.
• Made recommendations to improve and streamline operations including cost saving measures within the laboratories, make independent decisions on the organization of the laboratories.
• Served as the GLP Safety Manager within the AHRA chromatography laboratories which include conducting routine inspections with an analyst(s) and report to Group Leaders and coworkers any adverse findings and recommended corrective actions for compliance.
• Perform and implement procedures from established chromatographic methods.
• Clear and negotiate customs regulations on national and international shipments
• Performed Vendor audits with the QA department for COTS software being used in the laboratories
• Managed and wrote the implantation plans for Performance Qualifications (PQ) for all regulated CADS and laboratory equipment
Set-up and Installation of new site 1/2002 – 6/2002
• Responsible for project management of the new site from start to finish
• Coordination with Senior Management, Engineers and trade Unions to develop project plan for the site transition and start-up new location
• Coordination with IT on the upgrade and validation of new servers, hardware/software, telephony lines, data connections, and desktop computing.
• Tracked, monitored and reported project performance to team and stakeholders with daily, weekly and phase specific performance metrics
• Provided implementation and migration support
• Interfaced with customer and implementation teams
• Reviewed and oversaw software integration plan, hardware integration plan and rollout strategy
• Planned and managed data migration and certification/validation for compliance with FDA, EPA and local regulatory authorities
• Managed and coordinated on site roll-outs
• Issued daily management and tracking analytical reports
• Hosted training sessions
• Developed project schedules, vendor communications and coordinated maintenance and upgrade activities
• Provided management oversight of vendors, service contractors etc.
• Held principal oversight and virtual team responsible for hardware upgrade and application roll-out.
Site/Lab Operations Management 12/94- 12/2002
Operations 8/87 – 11/94
EDUCATION:
Pennsbury High School 1979 H.S. Diploma
Levittown, PA
Bucks County Technical School 1977 Electronics
Levittown, PA
PROFESSIONAL TRAINING AND CERTIFICATES
Ethics an Adversity Training/ National & International 2009/2010
Decision Excellence Fundamentals v07, 2008
Leadership Priorities Employee Engagement Session v08, 2008
ChemStation Plus Administration, 2005
Audits of Computer Systems in Laboratories and Manufacturing by Huber, Agilent Technologies, 2004
CGMP Annual Update Course by M. Bennett, 2004
21 CFR Part 11 Workshop, 2003
Microsoft Windows 2000 Network Infrastructure certificate of achievement, 2004
Microsoft Windows 2000 Network Environment certificate of achievement, 2003
Implementing Microsoft Windows 2000 Professional and Server certificate of achievement, 2003
Microsoft Windows 2000 Network and Operating System Essentials certificate of achievement, 2003
TC C/S-System Management-System Maintenance Training Course, 2001
TC Client Server System Management I-System Installation Training Course, 2001
MS NT Essential Training Course, 2001
TCCS System Administration Training Course, 2001
Analytical Systems Manager’s Course by Hewlett-Packard Company, 1995
COMMUNITY/VOLUNTEER EXPERIENCE
2004-2010 Falls Township Economic Development Commission- Vice Chairman
2010-Present Falls Township Zoning Hearing Board- Chairman
2000- Present Bouncing Off The Walls- Owner
1980-1984 United States Marine Corps
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