Leah Dillon
Bern
Summary
CQV Engineer with two years’ experience in qualification of upstream, down, stainless-steel buffer vessel and clean utility systems. Graduate of MSc in molecular biology and biotechnology. Four years’ experience working in GMP, GEP, GLP, and various graded cleanroom environments. Currently holding a Swiss B work permit and a full clean driver’s license.
Overview
4
4
years of professional experience
Work History
CQV Engineer
Thermo Fisher Scientific
Lengnau
08.2023 - Current
- Co-ordinated post-approval of commissioning documentation of Buffer Vessels and handover to qualification
- Managed update and approval of system parameter documentation via COMOS, including QRAs, alarm and parameter lists, and IOQ protocols
- Executed CIP testing of COP stations run through PCS7 during commissioning phase
- Supported Installation Verification of DSP systems, component verification, P&ID walkdowns, material cert verification, weld documentation and isometric checks.
- Documented all engineering activities according to ALCOA+, GMP and FDA guidelines.
- Performed Clean Utility Commissioning and Qualification with Sigren automation, including alarm and interlock testing, automatic valve testing, functional specification testing, system parameter control and max load testing.
- Supported Clean Utilities Task Force which was set up to deliver OQ closure for system PQ and GMP engineering runs when running behind schedule.
CQV Engineer
KPC International
WuXi Biologics
11.2022 - 08.2023
- Responsible for Upstream process IOQ execution. This involved qualification of Thermo Fisher single use bioreactors operated through DeltaV, and Cytiva Wave Bioreactors.
- Executed PID tuning of single use bioreactors during commissioning phase.
- Composed GMP risk assessments, proposing and justifying leveraging testing from commissioning to qualification.
- Co-ordinated Thermo Fisher vendor visits to site and supervised bioreactor SATs. Achieved post approval of associated test protocols.
- Successfully delivered all scheduled equipment under strict media test run deadlines.
- Executed CSV and AIS testing for equipment via DeltaV and Unicorn.
CQV Engineer
KPC International
WuXi Biologics
01.2022 - 11.2022
- Supported Downstream Process testing, responsible for IQ and OQ execution and GMP release of Cytiva chromatography columns.
- Witnessed and assisted in execution of SATs undertaken on AKTA Bioprocess Skids. Facilitated approval of associated documentation.
- Represented my workstream at daily document approval escalation meetings.
- Led Tier 1 workstream meetings weekly, allocated resources and reported issues requiring escalation to project manager.
- Generated and reviewed chromatography column IOQ protocol drafts and IOQSRs. Aligned with all departments to ensure requirements of all system users as outlined in URS were met and GMP requirements verified.
- Provided support to vendors and site contractors during the installation and calibration of equipment. Facilitated ECO completion of all Cytiva equimpent in manufacturing suites.
QA Analyst
The Coca-Cola Company
03.2020 - 01.2021
- Housekeeping roles included preparation of reagents, periodic instrument calibration, adherence to SOPs, and recording of results in SAP.
- Regularly co-ordinated microbiology lab, which included validation of aseptic conditions of the filling line and product storage
- Trained new personnel on QC procedures, including sampling techniques, and data recording and sample analysis according to GLP and GMP guidelines.
- Participated in internal audits and investigations into product and ingredient non-conformances.
Education
MSc - Molecular Biology and Biotechnology
Queen’s University Belfast
01.2021
Bachelor of Science - Biomedical, Physiology
NUI
Galway, Ireland11-2019
Skills
- Technical Writing- IOQ generation, QRA and parameter list update, IOQR generation
- Communication, regular representative of workstreams at site update and escalation meetings Class representative for multiple classes in University Canvassed for student union elections
- Conversant in Irish, achieved an A1 grade in French Leaving Cert examination
- IT/CSV/AIS Skills: Minitab, Graph Pad Prism, Microsoft Office, DeltaV, Unicorn, Sigren Automation software, PCS7
Timeline
CQV Engineer
Thermo Fisher Scientific
08.2023 - Current
CQV Engineer
KPC International
11.2022 - 08.2023
CQV Engineer
KPC International
01.2022 - 11.2022
QA Analyst
The Coca-Cola Company
03.2020 - 01.2021
MSc - Molecular Biology and Biotechnology
Queen’s University Belfast
Bachelor of Science - Biomedical, Physiology
NUI
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