James O'Mahony-Hackett

Manufacturing Engineer II | Validation (IQ/OQ/PQ) | GMP | Process Improvement | MedTech | OEE & Yield Optimisation

Callan, County Kilkenny, Ireland

About

Manufacturing Engineer with 5+ years’ experience in the MedTech industry, specialising in equipment and process validation (IQ/OQ/PQ), continuous improvement, and manufacturing scale-up in GMP-regulated environments. Currently working with Bausch + Lomb, leading validation activities and process improvements within high-volume contact lens manufacturing. Proven ability to deliver complex validation projects, support capacity expansions, and drive measurable improvements in yield, efficiency, and equipment performance. Strong background in cross-functional collaboration, working closely with Quality, Operations, and Engineering teams to ensure compliance with regulatory standards while achieving operational targets. Key strengths include validation execution, root cause analysis, process optimisation, and technical documentation in fast-paced, highly regulated manufacturing environments.

Experience

  • Manufacturing Engineer II at Bausch + Lomb Ireland
    May 2024 - Present · 2 yrs 2 mos

    Responsible for supporting high-volume contact lens manufacturing operations, with a focus on equipment validation, process optimisation, and continuous improvement in a GMP-regulated environment. Key Achievements: IQ/OQ/PQ validation of six manufacturing lines for major production expansion Executed process validation (PQ/PV) for second-source chemical materials Delivered cross-functional initiatives to improve yield performance Completed validation of second-source aluminium foil materials Reduced equipment downtime and improved OEE through machine design improvements Coordinated multi-department validation activities ensuring on-time project delivery

  • Project Engineer II at G-CON Manufacturing
    Sep 2021 - May 2024 · 2 yrs 9 mos

    Managed and supported the design, manufacture, and delivery of modular cleanroom POD systems, ensuring compliance with client requirements and quality standards. Key Achievements: Supported FAT and SAT execution including client inspections Reviewed engineering drawings to ensure compliance with URS Managed client material submittals and approvals Delivered manufacturing and installation support from build to final handover Developed visual work instructions to standardise processes Led design discussions identifying improvement opportunities and cost savings Created conceptual MobilePOD design using Revit

  • Manufacturing Engineer at Abbott
    Jul 2019 - Sep 2021 · 2 yrs 3 mos

    Delivered manufacturing engineering support in a cleanroom environment, focusing on safety, capacity, and process optimisation using Lean methodologies. Key Achievements: Led safety improvement projects reducing high-risk issues Applied DMAIC methodology for structured problem solving Supported new product introduction through tooling and process updates Delivered cleanroom layout redesigns for capacity expansion Managed project budgets and performance tracking Presented updates at management review meetings

  • Manufacturing Engineering Intern at Abbott
    Mar 2018 - Sep 2018 · 7 mos

    Delivered equipment improvement project on automated flushing system Conducted data analysis and presented findings to management Led safety walks and onboarding support for new employees

  • Process Engineering Technician at Ornua
    Jun 2017 - Aug 2017 · 3 mos

    Analysed process waste streams and implemented improvements Supported commissioning of sampling equipment