KIMBERLY LAMPHERE

KIMBERLY LAMPHERE

1113 Balley Dr. | Phoenixville, PA 19460 | 610.608.4433 | lampkimb@yahoo.com

SUMMARY OF QUALIFICATIONS
Senior Validation Consultant with experience in validation of PLC and DCS software applications. Additional experiences include pharmaceutical processing and automation experience in preparation and execution of automation System Lifecycle Documentation including Quality Assurance Plan, Configuration Management Plan, User Requirement Specifications, Functional Requirement Specifications, Detailed Design Specifications, Automation Test Plan, IQ/OQ documentation Requirements Trace Matrices, Retirement Plans and Quality Assurance Summary Reports.
SKILLS PROFILE
– Emerson DeltaV (Continuous and Batch applications)
– Development of System Life Cycle documentation
– Validation of automation systems and automated equipment
EMPLOYMENT HISTORY
Apro Resources, Senior Consultant
2009 — Current
Pharmaceutical Processing Facility – Debottlenecking Project, Oceanside, CA
– Expansion and upgrade of existing DeltaV DCS system. Area Lead for Fermentation and Formulation. Principal duties included management of team members, tracking and distribution of work assignments, development of automation System Life Cycle documentation (IQ/ OQ/ PQ documentation) and execution of acceptance and performance qualifications.
Pharmaceutical Processing Facility – D3 Upgrade Project, West Point, PA
– Upgrade of a D3 DCS system. Project Manager – Principal duties included monitoring project scope and developing/ administrating the project engineering change request process as well as serving as the primary liaison between the end user and the DCS manufacturer’s design engineering group. Monitoring staff productivity using routine progress reports that included, time reporting, travel expenses, cash flow projections. Providing direction and guidance to the project team on project planning, project execution, scheduling, resource placement, and project progress reports. Development and execution of automation System Life Cycle documentation (VMP, AIQ, AOQ, Data Migration Plan, and QASR).
Vaccine Manufacturing Facility – Rensselaer, NY
– Multiple projects – Project Manager and resource management. Additional duties included development and/ or review of automation documentation: HFAT, SFAT, FRS, DDS and RTMs.
Vaccine Manufacturing Facility – B40 DeltaV Project, Upper Merion, PA
– Upgrade of existing DeltaV DCS system. Principle duties included project quality oversite and review of all automation documentation (Factory Acceptance Tests, FRS, DDS, and IQ/OQ documentation), to ensure testing accuracy and completion prior to clinical runs.
Zenith Technologies, Senior Validation Consultant
2006 — 2009
Pharmaceutical Processing Facility – B300 DeltaV Project, Clayton, NC
– Upgrade of existing DeltaV DCS system. Principle duties included coding both batch and regulatory control portions of the DeltaV control system, including equipment modules, phases, operations and unit procedures. Internal software testing of equipment modules, phases, operations and unit procedures including the remediation of faults and the modification of design specifications and software code.
– Delivered DeltaV classroom training for 115 engineers with experience ranging from Operator through Administrator. Developed all associated technical training materials.
Pharmaceutical Processing Facility – Holy Springs, NC
– Provided a customer specific DeltaV training course to operators, process engineers and maintenance staff.
Pharmaceutical Processing Facility – B56 Remediation Project, Swiftwater, PA
Principle duties included providing customer project management with documentation of project progress, working with the Systems Integration company as a client representative, led the effort in the execution of commissioning protocols relating to Utilities, 30L, 300L, and 3000L Fermentors, CIP Storage, Buffer, Media Preparation and Recovery areas, testing regulatory control portion of the DeltaV control system, including functional testing of equipment modules, loop checks, and verification of configuration correspondence to operator interface. Pharmaceutical Processing Facility – B59 Commissioning Project, Swiftwater, PA
– Principle duties included development and execution of leveraged commissioning protocols for the Ultrafiltration/Diafiltration skids. Development of UF/DF Standard Operating Procedures and Requirements Trace Matrix.
Valspec, Validation Consultant
2001 — 2006
Pharmaceutical Processing Facility – Suite 3 DeltaV Upgrade, Upper Merion, PA
– Upgrade of existing DeltaV DCS system. Developing and executing Operational Qualification testing for Hold and Abort logic for the Media, Buffer, CIP/ COP, Fermentation and Purification areas.
BioTech Facility – Pearl River, NY
– DeltaV DCS system. Principle duties included monitoring of project scope and developing/ administering the project engineering change request process. Monitoring staff productivity using routine progress reports that included, time reporting, travel expenses, cash flow projections. Review and execution of acceptance testing.
Pharmaceutical Processing Facility – Full Scale Development Project, Sanford, NC
– DeltaV DCS system. Served as a Lead Engineer for a 15 person execution team in a Biopharmaceutical facility with a newly installed DeltaV control system. Monitored staff productivity. Provided customer project management with documentation of project progress. Developed and executed Installation Qualifications and Operational Qualifications for both batch and regulatory control portions of the DeltaV control system.
Pharmaceutical Processing Facility – Varicella Project, West Point, PA
– DeltaV DCS system. Developed and reviewed: Installation Qualifications, Operational Qualifications, Standard Operating Procedures and Validation reports including 21 CFR Part 11 components of computer systems for process control systems. Developed System and Process Standard Operating Procedures for System Security, Backup and Restore, Change Control, Maintenance, Disaster Recovery, Training, and Operation. Executed Installation Qualifications, Operational Qualifications including 21 CFR Part 11 components of computer systems for process control systems.

EDUCATION
– B.A., Psychology, West Chester University
TRAINING
– Introduction to Process Control – 9000
– DeltaV System Implementation – 7009
– DeltaV Batch Implementation – 7016