Ashley Kinney
Frederick
Summary
Dynamic Computer Systems professional with over twelve years in the pharmaceutical sector. Expertise in developing and validating automation processes, ensuring compliance with cGMP standards, and enhancing operational efficiencies through effective lifecycle management.
Overview
13
13
years of professional experience
Work History
Senior Automation Engineer
AstraZeneca
Frederick
11.2018 - Current
- Serve as Subject Matter Expert (SME) for Rockwell Automation systems and associated manufacturing automation platforms.
- Led automation activities for operational improvements and capital projects from design through implementation and commissioning, ensuring successful project execution.
- Support lifecycle management activities for computerized systems, including system enhancements, upgrades, maintenance, and change implementation.
- Investigated deviations, system issues, and operational incidents to minimize downtime and ensure validated system performance.
- Managed system specifications, including Function Requirement Specifications and Detailed Design Specifications, to support compliant operations.
- Collaborate cross-functionally with Engineering, Manufacturing, Quality Assurance, Validation, and IT teams to support compliant system operation and project execution.
- Author and execute scripted and unscripted test protocols for implementation of changes to the computerized system, specifically supporting automation changes related to process phases, SIP (Steam-In-Place), and CIP (Clean-In-Place) phases.
- Review and approve electrical control panel drawings and automation-related technical documentation.
- Perform periodic review and maintenance of Standard Operating Procedures (SOPs) to ensure compliance with cGMP requirements and internal quality standards.
Automation Validation Engineer
AstraZeneca
Frederick
11.2018 - Current
- Managed automation IOQ protocols and specifications throughout life cycle using document management system.
- Developed and executed Installation Operational qualification protocols on a computerized system, focusing on automation changes for process phases, SIP phase, and CIP phases.
- Interacted with developers, engineers, and system owners to facilitate timely protocol execution and resolve issues during development and execution.
- Troubleshot and resolved issues discovered during testing.
- Work directly with project team to ensure completeness and accuracy of protocol content.
- Coordinating with Change Control owners and project team to complete tasks prior to date due.
- Author final reports summarizing execution of IOQ.
- Maintained adherence to current Good Manufacturing Practices (cGMP) to ensure quality standards.
Control systems Developer I
Matrix Technologies
Frederick
01.2017 - Current
- Managed automation IOQ protocols and specifications throughout their entire life cycle via document management system to ensure compliance and quality control.
- Authored and executed installation operational qualification protocols on a computerized system for automation changes related to process phases, SIP phase, and CIP phases.
- Interacted with developers, engineers, and system owners to facilitate timely execution of protocols and resolve issues during development and execution.
- Coordinated with change control owners and project team to ensure timely completion of tasks ahead of deadlines.
- Work directly with project team to ensure completeness and accuracy of protocol content.
- Author final reports summarizing execution of IOQ.
- Implemented current good manufacturing practices to ensure compliance with industry standards.
Automation Validation Contractor, on behalf of AstraZeneca Supply Biologics
Aerotek
Frederick
02.2014 - 12.2016
- Author and execute Installation Operation Qualifications for automation for a Rockwell based Process Control System using Functional Requirement Specifications and Detailed Design Specifications.
- Validate automation processes, such as Process Phases, SIP Phases, and CIP phases, on a development simulator before new or modified automation is installed onto live system.
- Manage automation IOQ protocols throughout their entire life cycle via document management system.
- Current Good Manufacturing Practice (cGMP).
Bank Teller
PNC
Frederick
10.2013 - 02.2014
- Provided account services to customers by receiving deposits and loan payments; cashing checks; issuing savings withdrawals; recording night and mail deposits; selling cashier's checks and traveler's checks.
- Answered customer questions in person and on telephone; referring to bank services.
- Recorded transactions by logging cashier's checks, traveler's checks, and other services.
- Informed customers of new services and product promotions.
- Completed special requests by taking orders for checks, providing statements, copies, and referrals; and completed safe-deposit box procedures.
Education
Bachelor of Science - Biology, Chemistry
Shepherd University
Shepherdstown, West Virginia05-2013
Skills
- Automation tools
- Process Optimization
- Proficiency with Microsoft Office and Excel
- Issue troubleshooting
- Time Management
- Self-motivation
- Collaborative Problem Solving
Languages
English
Timeline
Senior Automation Engineer
AstraZeneca
11.2018 - Current
Automation Validation Engineer
AstraZeneca
11.2018 - Current
Control systems Developer I
Matrix Technologies
01.2017 - Current
Automation Validation Contractor, on behalf of AstraZeneca Supply Biologics
Aerotek
02.2014 - 12.2016
Bank Teller
PNC
10.2013 - 02.2014
Bachelor of Science - Biology, Chemistry
Shepherd University