Olivia Thompson

• Phone: +353 87 123 4567
• Email: olivia.thompson@email.com
• Location: Dublin, Ireland
• LinkedIn: oliviathompsonvalidation

Summary

Over 6 years of experience in pharmaceutical validation, specializing in GxP environments and ensuring compliance with regulatory standards (FDA, EMA). Successfully led validation efforts for critical manufacturing equipment and processes, improving system reliability by 15% and reducing audit findings by 20% in previous roles.

Adept at developing and executing validation protocols (IQ, OQ, PQ), managing risk assessments, and authoring comprehensive validation reports for sterile manufacturing and API production facilities.

Experience

Senior Validation Engineer, Perrigo Ireland -- Dublin, Ireland

Mar 2021 – present

• Led validation lifecycle activities for new sterile filling lines, including design review, FAT/SAT, IQ/OQ/PQ protocol development, and execution, ensuring GAMP 5 compliance.

• Managed a portfolio of 10+ validation projects simultaneously, reducing typical project timelines by 10% through effective planning and stakeholder coordination.

• Authored and reviewed C&Q documentation for process equipment, utilities, and analytical instruments, resulting in successful regulatory submissions.

• Implemented a revised Computer System Validation (CSV) strategy for SCADA and PLC systems, enhancing data integrity and audit readiness across manufacturing operations.

Validation Engineer, Jazz Pharmaceuticals -- Athlone, Ireland

June 2018 – Feb 2021

• Executed equipment qualification (IQ/OQ/PQ) for various biopharmaceutical manufacturing systems, including bioreactors, chromatography skids, and clean utilities.

• Developed and maintained validation master plans, ensuring alignment with corporate quality standards and regulatory requirements.

• Performed routine revalidation activities and periodic reviews of validated systems, identifying and resolving potential compliance gaps.

• Collaborated with cross-functional teams (Engineering, Quality Assurance, Manufacturing) to troubleshoot validation issues and implement corrective actions.

Education

University College Dublin, B.Eng. in Chemical Engineering -- Dublin, Ireland

Sept 2014 – May 2018

Skills

Validation Methodologies: IQ, OQ, PQ, CSV, Process Validation, Cleaning Validation, Equipment Qualification, GAMP 5, Risk-Based Validation

Regulatory & Quality Standards: FDA 21 CFR Part 11, EU Annex 11, GxP (GMP, GLP, GCP), ISO 13485, Data Integrity, CAPA, Change Control

Software & Tools: ISPE GAMP, MasterControl, TrackWise, QMS Systems, Microsoft Office Suite, Statistical Process Control (SPC)

Technical Expertise: Sterile Manufacturing, Aseptic Processing, API Production, Utilities (WFI, Clean Steam, Compressed Air), HVAC Systems, Bioreactors, Chromatography

Soft Skills: Project Management, Technical Writing, Root Cause Analysis, Cross-functional Collaboration, Problem-solving, Audit Support