Summary
Overview
Work history
Education
Skills
Accomplishments
Timeline
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Annie Phelan

Myshall,County Carlow

Summary

Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.

Joined ADC Kilkenny in December 2023 to develop professionally gain experience in the qualification of a medical device facility focusing on EBEAM sterilization and dosimetry. In July 2024 I was promoted from dosimetry lab supervisor to dosimetry process engineer, where I was involved in the first Abbott owned IOQ and PQ of the EBEAM. In February 2024 the team travelled to Aerial in Strasbourg, where we received expert training in EBEAM qualification. Most recently received 'Project Liberty' award for contributions to ADC Kilkenny facility start up.

In May 2021 I joined the Carlow Expansion Project worked as a part of the syringe suite team involved in achieving all project milestones such as the most recent Syringe PPQ batches, PSIM and Campaign PSIM which were all carried out safely and on time.

In that time I also designed and expedited a new curricula framework to support the syringe filling team. This seen the generation of new operating procedures as well as amalgamating existing procedures with the aim of making a new leaner process. As well as delivering training through train-the-trainer to support manufacturing readiness.

Experienced in VV and MEDS and I am familiar with the process involved in document system workflow as well as liaising with cross functional departments such as Quality and PSS on any documentation generation that arise through any operational activities.

Managed the deployment of Lean six sigma 5s for the syringe manufacturing area, This role involved coordinating with individual room owners on a weekly basis to ensure the plan was going ahead and also assigning tasks for the coming week. The overall deployment was a success when the site achieved a better than anticipated result in an audit to assess out readiness for manufacturing.

Operations Co-Ordinator for GMP Release ensuring all testing had been carried out to a standard set by the governing bodies in the industry. This involved collecting and transferring data in a way that proved all testing had been carried out accordingly and the area was ready to produce commercially, Including tracking all CAPAs associated with the areas.

Overview

5
5
years of professional experience

Work history

Dosimetry Process Engineer

ADC Kilkenny
Kilkenny, County Kilkenny
07.2024 - Current
  • Executed dosimeter calibration and verification activities to support EBEAM activities
  • Presented project milestones in a professional setting to senior leadership and VPs on a regular basis.
  • Executed EBEAM IOQ and PQ activities.
  • Identified areas of improvement with regular audits and assessments.

PRODUCTION TECHNICIAN

MSD Carlow
Carlow, County Carlow
08.2020 - 12.2025


  • Area Owner for 5s in Syringe Area
  • Room owner for Syringe Filling
  • Implemented 5s standards across syringe suite
  • Completed PSIMS and fully qualified in the Syringe filling isolator Experience with MES and Delta V systems
  • Communicated with individual room owners ensuring syringe area was audit ready and maintained as per 5s standard
  • Syringe lead for the curricula building workshop in conjunction with L&D dept
  • Created training curriculum based on forward planning and experience of the tasks involved in the syringe filling suite
  • Achievement: Successful deployment and auditing of 5S role out in Syringe Suite.

Dosimetry Lab Supervisor

ADC Kilkenny
Kilkenny, County Kilkenny
12.2024 - 07.2025
  • Responsible for overseeing the GEX IQ of the equipment and software.
  • Creation and implementation of dosimetry related documentation.
  • Organised face-to-face workshops with internal SMEs and supporting stakeholders.
  • First ADC, Kilkenny Audit ready room captain.

Education

QQI Level 5, Green Belt - Lean six sigma

DCM Learning

Cerificate in Biopharmaceutical Operations - Biopharmaceuticals

SETU Carlow
carlow

BA (Hons) Human Resource Management - Human Resource Management

Carlow Institute Of Technology
car;pw

Skills

Microsoft Office

Delta V

Glims

Veeva Vault

MES

SAP

Maximo

Accomplishments

Received 'Project Liberty Award' for contributions to ADC Kilkenny facility startup,

Timeline

Dosimetry Lab Supervisor

ADC Kilkenny
12.2024 - 07.2025

Dosimetry Process Engineer

ADC Kilkenny
07.2024 - Current

PRODUCTION TECHNICIAN

MSD Carlow
08.2020 - 12.2025

QQI Level 5, Green Belt - Lean six sigma

DCM Learning

Cerificate in Biopharmaceutical Operations - Biopharmaceuticals

SETU Carlow

BA (Hons) Human Resource Management - Human Resource Management

Carlow Institute Of Technology
Annie Phelan