Anddy L. Email & Phone Number

Blue Bell, PA, US

• Run meetings, communicate status, and project issues, frequently check in with client representative(s), and facilitate general project coordination activities.
• Coordinates project activities with the Project Lead.
• Perform work to meet budget requirements and quality standards.
• Provide consistent, complete, and timely feedback and reports to clients or management of project status and issues.
• Develop project schedules, deliverable tracking reports, scope adjustment notices, etc.
• Support, train, mentor, and provide guidance to commissioning and validation specialists/engineers and project leaders in the delivery of C/Q/V services for assigned projects.

Fishers, Indiana, US

• Led modernization project for laboratory environments, upgrading systems and implementing disaster recovery solution.
• Successfully transitioned systems to Windows 10, enhancing security and efficiency.
• Established comprehensive disaster recovery plan ensuring data integrity and system resilience.
• Managed team performance, client relations, and business development, contributing to account growth.
• Oversaw system upgrades, disaster recovery, and team development.
• Conducted regular one-on-one meetings, facilitated recruitment, and generated project proposals.

Fishers, Indiana, US

• Led a project to modernize data management and integration capabilities of laboratory instruments through GxP system validation.
• Successfully integrated LabX software with Mettler Toledo analytical instruments, implemented Smartline Data Cockpit, and deployed Tetrascience Data Platform for comprehensive data aggregation.
• Developed validation documents following defined CSV process and led risk-based validation of GxP systems.
• Communicated project progress throughout system lifecycle, ensuring stakeholders were informed.
• Validated system implementations, upgrades, and created documentation in accordance with validation plan and protocols.
• Delivered comprehensive suite of validation documents including Validation Plan (VP), User and Functional Requirements (URS), Requirements Traceability Matrix (RTM), and Validation Summary report.

Rochester, NY, US

• Project Management:
• Developed detailed Project Plan in Smartsheet PM System and managed effective execution.
• Coordinated team resources to ensure delivery of plan and flawless execution of deployments.
• Ensured each deployment was delivered on time & within financial budgets.
• Intricate knowledge of Project Status and clear KPI’s & Reporting (Smartsheet) in place to evidence.
• Proactively identified and facilitated the resolution of potential risks to the critical path of projects.

Hatboro, Pennsylvania, US

• Cleaning Validation:
• Drafted development and Validation Protocols related to Clean-in-Place (CIP) cycles of bulk manufacturing and related cleaning of manufacturing equipment.
• Worked with manufacturing to optimize CIP cycles to reduce time and utility usage.
• Worked with manufacturing to optimize and validate cleaning processes.
• Qualification of Swab Recovery technique.
• Assisted with sampling CIP cycles via Rinse and Swan techniques.

Doylestown, PA, US

• Project Management:
• Developed detailed Project Plan in Smartsheet PM System and managed effective execution.
• Coordinated team resources to ensure delivery of plan and flawless execution of deployments.
• Ensured each deployment was delivered on time & within financial budgets.
• Intricate knowledge of Project Status and clear KPI’s & Reporting (Smartsheet) in place to evidence.
• Proactively identified and facilitated the resolution of potential risks to the critical path of projects.

Doylestown, PA, US

• Proposed risk-based processes for determining the Instrumentations’ Classifications and Calibration Intervals.
• Performed gap analysis on Calibration data against divisional best practice guidelines and assess the work required to eliminate gaps in the business process.
• Proposed means & methods of improving the current business process to achieve maximum efficiencies within the Calibration departments.
• Met regularly with all stakeholders to discuss progress, communicate changes, and manage the entire change effort.
• Aided in the development of Calibration SOPs and Calibration Work Instructions.
• Reported on project progression at daily/weekly meetings or at the request of the customer.

Doylestown, PA, US

• Proposed risk-based processes for determining the Instrumentations’ Classifications and Calibration Intervals.
• Performed gap analysis on Calibration data against divisional best practice guidelines and assess the work required to eliminate gaps in the business process.
• Proposed means & methods of improving the current business process to achieve maximum efficiencies within the Calibration departments.
• Met regularly with all stakeholders to discuss progress, communicate changes, and manage the entire change effort.
• Aided in the development of Calibration SOPs and Calibration Work Instructions.
• Reported on project progression at daily/weekly meetings or at the request of the customer.

Mentor, OH, US

• Prepared validation protocols, executed validation protocols, and generated summary reports for clients in the Pharmaceutical, Biotechnology, and Medical Devices industries.
• Interacted with clients in the field daily, Technical Writing / Protocols, Temperature Mapping, Autoclave Validation, Incubator Validation, Water System Validation, Dry Heat Ovens, HVAC / Cleanroom Validation, Lab.
• Maintained all assigned validation equipment and assured equipment was in calibration.
• Specialized in Environmental Monitoring, Viable sampling, Gown Certification, and Compressed Air Line Testing.

• Metrology Systems & Standards, Aerosol Photometry & Generation, Airflow Meters, Building Automation Systems, Conductivity, Dimensional Calibrations, Flowmeters, Light Meters, Optical Particle Counters, Pressure, RPM.
• Executed in-house and field Calibration for clients in the Pharmaceutical, Biotechnology, and Medical Devices industries.
• Addressed deviations found concerning the everyday use of materials tested and assisted the Quality Department deviation investigations.
• Ensured that the metrology laboratory conditions were appropriate for the testing performed and provided a safe environment in which employees were protected from physical and chemical hazards.
• Maintained all assigned Calibration equipment and tools.
• Completion of applicable paperwork trail, including checklists, generation of raw data, and final reports.