Hello, I'm Catherine.
Engineer. Problem Solver. Leader.
A problem-solver by nature. I use extensive data analysis as a platform for solving complex problems and making critical decisions — combining lean sigma methodology, bioprocess engineering, and a genuine curiosity for how systems work. I rely on both new and well-established tools to achieve results, and use adaptability, flexibility, and agility to stay ahead of the curve and hit deadlines. 7 years of Bio/Pharma experience, a first-class MEng and BEng from UCD, and post-graduate qualifications in Lean Six Sigma, Validation Technology, and Automation & Control.
Experience
7 years
Bio/Pharma industry
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Qualification
Black Belt
Lean Six Sigma
View project →
Education
BEng · MEng
UCD Ireland · 1.1
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What I do well
Bioprocess engineering
System ownership, process optimisation and validation across Grade A pharmaceutical manufacturing.
Root cause analysis
Led complex RCAs on critical deviations using 5-Whys, Fishbone, FMEA and A3 methodology.
Data analysis
Data-driven decisions under pressure — from trending and performance monitoring to CAPA delivery.
Validation (CQV)
IQ/OQ/PQ, PPQ, impact assessments, KNEAT authoring & approval across isolator and filling systems.
Lean Six Sigma
Black Belt certified (Distinction). DMAIC projects delivering measurable improvement in manufacturing.
Technical leadership
Led teams of 20, trained operators and technicians, and delivered cross-functional initiatives at AMGEN.
Projects
Decontamination reliability RCA
RCALed investigation into recurring decontamination cycle failures — identified root causes and implemented recipe modifications and equipment improvements to stabilise performance.
View project →
Parts management A3
LeanDeveloped and implemented a sitewide tracker to monitor isolator component usage, repair, and lifecycle status — reducing delays from missing or mismanaged parts.
View project →
Significant batch turnaround time reduction
AMGENDelivered sustainable engineering solutions — new equipment, automation recipes, MBR, SOPs and operator training — delivering significant reduction in line turnaround time per batch.
View project →
Pharma
The impact of technology on the future of medicine
Jan 2023
Pharma
Introducing cGMP — what you need to know
2023
Productivity
How to be adaptive in a dynamic world
2022
Productivity
3 ways I outsmart the lazy me
2022
Want to work together?
Drop me a message or contact me on LinkedIn.
Jump to
🌴
Career Break
Travelled around the world
2025 – 2026
AMGEN Ireland
2021 – 2025
Senior Engineer (System Owner) — Syringe Filling Isolator
Most recent role
2024 – 2025
Lead Engineer for overall performance, compliance, and validation readiness of syringe filling isolator systems, including associated subsystems across the filling line.
CQV & Validation — managed recipe and parameter updates, qualification impact assessments, and performance trending. Supported PPQ activities as a reviewer and approver.
RCA & FMEA — led detailed technical investigations into recurring equipment issues across the isolator system.
Cross-functional — partnered with Maintenance, CQV, Operations, and Quality teams. Delivered isolator training to operators and technicians.
Key achievements
Significant batch turnaround time reduction — delivered through new equipment, automation recipes, updated MBR and SOPs
Led decontamination reliability RCA — stabilised deco cycle through recipe modifications and parts replacement
Standardised recipes across campaigns, improving consistency and reducing setup time
Implemented sitewide parts tracker A3 to reduce delays from missing or mismanaged isolator components
Originated and led Women in Pharma Awards — 3 finalist nominations out of 5 categories
Manufacturing Front Line Manager
2023 – 2024
Team leadership — managed a large 24/7 manufacturing shift team; developed staff through 1:1s, coaching, and succession planning.
CQV support — partnered with Engineering, Process Development, and Maintenance on system impact assessments, PPQ coordination, and readiness tasks.
Operational oversight — coordinated daily production, ensured Formulation & Parts remained off the critical path through proactive scheduling.
Continuous improvement — applied DAI, RCA, and 5-Whys frameworks to sustain validated performance and system reliability.
Key achievements
Scaled the team from 15 to 20 — led end-to-end recruitment, structured onboarding, and full integration into a 24/7 shift operation
Built a culture of development within the team, directly supporting several members to achieve promotions through targeted coaching, 1:1s, and stretch opportunities
Identified and resolved upstream process bottlenecks that were placing pressure on the downstream critical path — improving schedule reliability and reducing firefighting across shifts
Manufacturing Specialist
2021 – 2023
Investigated highly complex major/critical deviations — RCA fish bones, risk assessments, technical reporting, and presentation to Senior Leadership Team.
Led investigations into critical deviations across sterile manufacturing operations.
End-to-end project management for investigations including CAPAs, EVs, and cross-functional coordination.
Key achievements
Major Deviation Lead for complex fill/finish investigations — end-to-end facilitation from RCA through CAPA closure
Drove efficiencies in the deviation process to reduce lead time and improve on-time, in-full closure rates
Distilled highly technical detail for diverse audiences across Tier 1, 2 and 3 communications
Active member of internal diversity, inclusion and belonging groups
Viatris (Mylan) OSD, Dublin
Process Engineer
2020 – 2021
Lead Process Engineer for the Granulation suite — coordinating cross-functional teams (Manufacturing, QA, QP, MSAT) for RCA, corrective actions, and regulatory compliance.
Lean Six Sigma Black Belt project — reduced deviation performance, cut overdue records, and improved investigation cycle time using DMAIC.
Key achievements
Closed a high volume of deviations spanning OOS results, cross-contamination, RFT, and equipment issues
HPRA Audit Lead for Critical/Major deviations — presented 2-year review with key summaries
Authored a large number of technical reports including RCA, impact assessments, and process investigation documentation
Lean Six Sigma Black Belt project — stabilised deviation performance, cut overdue records and improved investigation cycle time
Standardised RCA and CAPA workflows, improving Right First Time closure rates across the site
LEO Pharma, Dublin
Process Engineer
2019 – 2020
Implemented mix-proof valves to allow parallel CIP of piping alongside processing.
Led the introduction of the first ever Process Engineering / MSAT Graduate Program on-site.
Key achievements
IQ/OQ/PQ project lead delivering a process improvement that delivered significant time savings per batch
Founded the first Process Engineering / MSAT Graduate Program on-site — led full recruitment, goal-setting and management
Created and approved validation documentation for IPC equipment including IQ/OQ/PQ and URS
LEO Pharma "Pride of the Pack" Award recipient 2020
AbbVie, Cork
Manufacturing Engineer (MEng Internship)
2018
Managed production deviation systems — analysed process deviation trends and authored deviation reports.
Project lead on improving the Inspection Vision System.
Key achievements
Improved Vision System throughput by identifying and resolving process bottlenecks
L9 Diploma in Validation Technology (CQV)
NIBRT & TUD, Ireland
Sep 2023 – Jan 2025
Distinction
L8 Diploma in Automation & Control
NUIG, Ireland
Sep 2022 – Sep 2023
Distinction
L8 Certificate in Lean Six Sigma Black Belt
Munster Technological University (MTU)
Sep 2021 – Nov 2021
DMAIC, A3, 8-step problem solving, RCA, process mapping
Applied to site-wide deviation reduction project at Viatris
L9 MEng in Chemical & Bioprocess Engineering
University College Dublin (UCD)
Sep 2018 – Sep 2019
First Class Honours (1.1)
L8 BEng in Chemical & Bioprocess Engineering
University College Dublin (UCD)
Sep 2014 – Sep 2018
First Class Honours (1.1)
Awards
Intel UCD Master's in Engineering Scholarship 2018–2019
Intel Women in Technology (WIT) Scholarship 2014–2018
Significant batch turnaround time reduction
AMGEN
Implemented sustainable engineering solutions to significantly reduce line turnaround time between batches. Included equipment installation, automation recipe development, updated MBR, new SOPs, and technician/operator training. Delivered technical leadership throughout CQV phases including IOQ and PQ protocol writing.
AMGEN Ireland · 2024–2025
Decontamination reliability RCA
RCA
Led investigation into recurring decontamination cycle failures — identified root causes and implemented recipe modifications and equipment improvements to stabilise performance.
AMGEN Ireland · 2024–2025
Parts management A3
Lean
Developed and implemented a sitewide tracker to monitor isolator component usage, repair, and lifecycle status — reducing delays from missing or mismanaged parts across manufacturing campaigns.
AMGEN Ireland · 2024–2025
Lean Six Sigma Black Belt project
DMAIC
Delivered a 3-month site-wide deviation-reduction project at Viatris that stabilised deviation performance, cut overdue records, and improved investigation cycle time. Applied DMAIC methodology, RCA workshops, milestone tracking, and stakeholder alignment meetings.
Viatris (Mylan) · 2020–2021
Validation IOQs
CQV
Creation & execution of IOPQ documentation — Vision System Packaging Line IOPQ, Mixproof Valve IOQ, IPC Test Equipment IOQ. Full lifecycle from protocol authoring through execution and summary reporting.
AMGEN Ireland
Irish Women's Tag Rugby Team
Ireland International
2024
Represented Ireland at international level in Tag Rugby
Captain of the Irish Women's Tag Rugby Team 2024
Intel Women in Technology Scholarship
Intel Ireland
2014 – 2018
Recipient of Intel's Women in Technology (WIT) Scholarship throughout undergraduate degree
Intel UCD Master's in Engineering Scholarship
Intel Ireland
2018 – 2019
Awarded Intel scholarship to support MEng studies at University College Dublin
LEO Pharma "Pride of the Pack" Award
LEO Pharma Ireland
2020
Recognised for outstanding contribution and performance during tenure at LEO Pharma
Women in Pharma Awards
AMGEN Ireland
2024
Originated and led AMGEN's participation, securing multiple finalist nominations across categories
All articles
Pharma
The impact of technology on the future of medicine
Precision medicine, telemedicine, remote patient monitoring and what it means for healthcare.
Pharma
Introducing cGMP — what you need to know
Breaking down Good Manufacturing Practices for a general audience.
Productivity
How to be adaptive in a dynamic world
Technology has brought incredible changes. Here's how to stay ahead of the curve.
Productivity
3 ways I outsmart the lazy me
Habits, systems and the honest truth about getting hard things done.
Book review
Leadership Strategy & Tactics — Jocko Willink
Key lessons on leadership, decision-making and earning trust from those you lead.
v7.6