Colin Fitzsimons

A highly skilled and adaptable Biopharmaceutical professional with 20 years of high-volume manufacturing experience, specializing in aseptic techniques and sterile cleanroom operations (Grade C/Previral environments). Proven track record in facility start-up, site validation (FAT, CQV support), and process automation utilizing MES and Delta V.

Certified Lean Six Sigma Green

Belt with extensive experience leading process optimization, troubleshooting technical issues, and mentoring teams to achieve Right-First-Time execution.

Machine Operator (Validation – Bio Decontamination) - Siemens-Healthineers - Swords, Ireland

(2024-05 - 2026-02)

• Executed conditioning, cleaning, and optimization of critical machinery as an integral part of the Factory Acceptance Test (FAT) and validation process.
• Conducted swab analysis of components to ensure strict adherence to SOPs and sterile compliance.
• Performed final manufacturing sign-off on clinical diagnostic equipment prior to Quality Control inspection.
• Led the onboarding and training of new starters for the Bio-Clean environment.

Bio-Process Associate (BPA – Downstream) - QCS Staffing at MSD Biotech - Swords, Ireland

(2023-06 - 2024-05)

• Executed batch production of Monoclonal antibodies via aseptic techniques in a sterile, Previral cleanroom environment.
• Utilized MES and Delta V automation software to run and monitor batch manufacturing according to precise work instructions.
• Completed Electronic Batch Records (EBRs) in compliance with GMP, closing out quality exceptions in partnership with QA.
• Supported continuous improvement by redlining and reviewing SOPs and Work Instructions.
• Conducted visual inspections of stainless-steel tanks post-CIP and analyzed protein concentrations via UV-Vis Spectroscopy.
• Ensured site KPIs were met daily through adherence to Standard Work systems.

Bio-Process Associate (BPA – Upstream) - WuXi Biologics Ireland - Dundalk, Co. Louth

(2022-01 - 2023-06)

• Embedded within a cross-functional project team tasked with supporting the development and validation of a new manufacturing site.
• Optimized and troubleshot technical process issues for single-use bioreactors, centrifuges, and depth filtration equipment.
• Authored, reviewed, and updated critical SOPs and Master Batch Records (MBRs) to prepare the facility for operational readiness.
• Served as an active member of the Site Emergency Response Team.

Production Operator - Renishaw - Swords, Co. Dublin

(2021-09 - 2021-12)

• Assembled high-precision OMI optical transceivers for meteorology instrumentation, meeting daily volume targets.

Production Operator - Arvato SCM (Ireland) - Balbriggan, Co. Dublin

(2004-07 - 2016-12)

• Managed high-volume replication and reconciliation of customer media assets, processing 35,000+ units per shift.
• Executed weekly audits, calibrations, and Total Productive Maintenance (TPM) on high-speed equipment.
• Ran "First Article" mock productions for new product introductions and documented machine parameters.
• Logged accurate data outputs using SAP and OEE software to drive efficiency.

Bachelor of Science - Biopharmaceutical Science - Dundalk Institute of Technology (2018 - 2021)

QQI Level 5 Certificate - Applied Science (Laboratory Techniques) - Drogheda Institute of Further Education (2017 - 2018)

Green Belt - Lean Six Sigma - Cork Institute of Technology (2017 - 2017)