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.• Assist or take the lead in proposal development including scope definition, attend bid meetings, development of hours and cost budgets, proposal presentations, etc.• Write and manage others in the preparation of C/Q/V documents following established standards and templates.• Responsible for deviation investigation and resolution of problems and issues encountered during field execution activities.• Audit project deliverables to ensure compliance with established standards.• Provide working knowledge in the delivery of technical projects in these areas.• Develop client relationships and function as IPS liaison on project/client sites.• Assist in recruiting new staff members and promoting IPS to potential hires.• Make recommendations to IPS for project and procedural improvements.• Stay current (training, reading, professional organization involvement) with industry trends and current C/Q/V methodologies.

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.• Managed Performance and Development Review process for direct reports.• Attended leadership meetings, provided accurate project status updates, and submitted reports to Service Line Director.• Hosted bi-weekly one-on-one meetings with direct reports.• Led new employee recruiting, interviewing, and hiring decisions.• Drove house account expansion and new business development.• Supported organizational strategies and department improvements.• Played a direct role in sales to existing clients, identified new business leads, and presented services for expansion.• Generated proposals for new or expanded client projects.• Tracked project status and funding identified and mitigated issues and prepared for upcoming engagements.• Provided technical expertise to team members as needed.

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.• Facilitated verification and validation activities such as User Acceptance Testing (UAT), test execution, and documentation review.

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.• Reported & escalated to Operations Manager when needed. • Acted as Site SME & Trainer for SAP PM. • Provided Hypercare on-site when needed. • Team SME for SAP PM Data Building & Reviewing. • Team SME for SAP PM Data Migration Processes & CR’s. • Team SME for client Business Processes & expectations involved around the project. Client Relationship Management:• Facilitated internal and client Weekly Meetings – Focus Groups, Data Reviews & Project Progress Meetings. • Managed & protected the existing strong relationship between the company & the client. • Aimed to identify further business opportunities between the company & the client.• Cultivated collaborative relationships with internal and external team members. Team Management:• Lead day-to-day operations of project team members.• Set clear goals & provide direction to all project team members. • Delegated project tasks & set deadlines. • Conducted bi-weekly coaching sessions and bi-annual reviews with each team member ensuring performance was being accurately monitored. • Discovered training needs & provided coaching where necessary. • Lead, motivate & encouraged team members to perform to their highest ability. • Onboarded new team members & ensured all mandatory training were completed.

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.• Contributed to the resolution of aberrant CIP results and aberrant cleaning results.• Compiled data and generated validation reports.• Deviation Resolution and Management• Categorized deviations by workstream/track (Manufacturing, QC, Engineering, etc.).• Prioritized deviations by criticality (Impact, Schedule, etc.).• Distilled sorting by product, batch, equipment, etc.• Developed standard process to streamline activities.• Consolidated deviations with like-root cause.• Developed project plan and schedule in alignment with client objectives.• Performed investigations, root cause analysis, and determined impact.• Collected relevant and related data, records, documentation, and hosted interviews with identified client resources.• Authored, Revised, and Reviewed supporting GMP documentation (SOPs, Work Instructions, Workflows, and related records).• Performed thorough quality checks and peer reviews.• Routed documents for review and approval through QMS.• Informed project stakeholders of progress, delays, or bottlenecks to collaborate and devise solutions.• Established relationships with project stakeholders, project team, and workstream champions.• Identified the escalation process for rapid responses and decisions.

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.• Reported & escalated to Operations Manager when needed. • Acted as Site SME & Trainer for ProCal. • Provided Hypercare on-site when needed. • Team SME for ProCal Data Building & Reviewing. • Team SME for ProCal Data Migration Processes & CR’s. • Team SME for client Business Processes & expectations involved around the project. Client Relationship Management:• Facilitated internal and client Weekly Meetings – Focus Groups, Data Reviews & Project Progress Meetings. • Managed & protected the existing strong relationship between the company & the client. • Aimed to identify further business opportunities between the company & the client.• Cultivated collaborative relationships with internal and external team members. Team Management:• Lead day-to-day operations of project team members.• Set clear goals & provide direction to all project team members. • Delegated project tasks & set deadlines. • Conducted bi-weekly coaching sessions and bi-annual reviews with each team member ensuring performance was being accurately monitored. • Discovered training needs & provided coaching where necessary. • Lead, motivate & encouraged team members to perform to their highest ability. • Onboarded new team members & ensured all mandatory training were completed.

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.• Carried out all Technical Data Reviews and entries on the system.• Translated & Cleansed Raw Data in preparation for the Data Migration.• Converted paper-based Calibration to a paperless format.• Prepared the facility for migration of their revised data in line with the Data Migration Plan.

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.• Carried out all Technical Data Reviews and entries on the system.• Translated & Cleansed Raw Data in preparation for the Data Migration.• Converted paper-based Calibration to a paperless format.• Prepared the facility for migration of their revised data in line with the Data Migration Plan.

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 Washers, Generator (Power) Validation, Compressed Airline Testing Validation, Biological Safety Cabinet / Laminar Flow Clean Bench Validation.• 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 Displays, Scales & Balances, Sound Meters, Temperature/Humidity, Timing Devices, and Viable Sampling Equipment Calibration Procedures.• 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.