Experience

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  Morans of the weir

  Jul 2008 - Aug 2008

  Kitchen porter

  • General kitchen duties• Collected and cleaned chef equipment, cutlery, glasses and plates.

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  Lydon house catering

  Jul 2010 - Aug 2010

  Chef assistant & kitchen porter

  • General kitchen duties• I was designated chef for fast food.• I had the responsibility of keeping sufficient food cooked at all times to meet the demand• I had to keep my area clean and tidy and working efficiently at all times• I was responsible for maintaining the Health and Safety standards of the company in my area.

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  Lydon house catering

  Jul 2011 - Aug 2011

  Maintenance & customer service

  • Maintain the outdoor restaurant in a clean and presentable manner• Ensure all customers are attended to in an efficient and friendly way• Deal with any customer’s queries and problems

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  Javas

  May 2012 - Jun 2012

  Barista/waiter/kitchen porter

  • Make different tea and coffee beverages• Clean all glasses, cups, plates and cutlery • Record customer orders (waiter) • Serve dishes to customers• Keep café hygienic at all times and presentable

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  Galway oyster hotel

  Jun 2012 - Oct 2012

  Waiter/ bartender

  • Prepare tables and serve residence / tours• Set morning buffet food and drinks• Restock food at end of breakfast• Clean restaurant to hygienic standards at the end of dinner• Follow room service orders• Counted cash and closed the cash register with recorded receipts at the end of shift.

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  Oranmore lodge hotel conference and leisure centre galway

  May 2013 - May 2015

  Waiter

  • Take charge of the set up and service of the breakfast / lunch operation• Serve guests in an efficient and friendly manner• Take food/beverage orders efficiently and charge accordingly• Carry out daily cleaning duties in the food and beverage areas• Adhere to the hygiene, health and safety, manual regulations of the company • Carry out any other reasonable request made by management from time to time• Train new waiting staff

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  Nuig

  Sept 2014 - Dec 2014

  Undergraduate student researcher/ laboratory demonstrator

  • Performing laboratory tests in order to produce reliable and precise data to support scientific investigations• Carrying out routine tasks accurately and following strict methodologies to carry out analyses• Preparing specimens and samples• Constructing, maintaining and operating standard laboratory equipment, for example centrifuges, pipetting machines and pH meters• Ensuring the laboratory is well-stocked and resourced• Recording and interpreting results to present to senior colleagues• Using computers and performing mathematical calculations for the preparation of graphs• Conducting searches on identified topics relevant to the research• Following and ensuring strict safety procedures and safety checks.• Demonstrator of basic microbiology for second year students Show less

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  Big bus tours

  Jun 2015 - Aug 2015

  Ticket agent

  • Responsible for selling Company tour tickets (primary Revenue)• Attracting suitable customers from the public and communicating appropriately • Dealing with competing tour companies on site, increase sales pitch strategy• Close sales at the best possible price• Customer service complaints, issues and refunds• Manage cash and credit balances at end shift

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  Medtronic

  Jan 2016 - Apr 2017

  Key Responsibilities:-Worked with a team to support the creation of new quality management system for a joint venture company in Russia-Converted required documents in accordance to the style guide under direction of the writers by assigned deadlines.-Audited created document procedures and training materials.-Maintained a metrics file using excel to track progression of document implementation.-Created and maintained a map of the new quality management system using Visio-Prepared change order supportive documents for Agile. Achievements:- As part of the project team, I was responsible for the creation and maintenance of a Quality Manage System (QMS) reference Map using Visio. This map was built to reflect the relationships between actual documents using correct names and document numbers. This will be a supporting material (appendix) to the new joint venture company quality manual.- I was responsible for an individual work project which required the completion of QMS documents that were manually implemented, to be updated with unique Agile identifiers. I had to communicate with authors to make any additional required corrections. I in turn created an excel tracker which was used as means of tracing project progress (excel). All documents were put up for CO and approved. Show less Key Responsibilities:- Environmental monitoring of 10 cleanrooms on the site.- Ensured that all testing was completed and recorded according to Good Documentation Practices (GDP) and relevant SOPs governing documentation and reporting.- Initiated appropriate corrective action where non-conformances/deviations were found and followed-up to ensure the appropriate steps were implemented (Environmental failures)- Carried out validation testing/ re-qualifications & non routine testing within the lab and manufacturing areas using appropriate protocols.- Provided day to day support to manufacturing areas.- Prepared media for bioburden/ environmental testing (Growth promotions, Sterility)- Performed bioburden and LAL testing to schedule- Plotted trending data analysis of all testing in a timely and effective manner.- Continuously reviewed standards to ensure that Good Laboratory Practices are adhered to.- Training of other lab personnel and also GMP Induction Training.- Liaising with other departments E.g. facilities, manufacturing, chemical lab as well as external vendors (Reagecon)Achievements:- I supported on a project focusing on the establishment of an Environmental Risk Assessment method of the cleanrooms. I establish the most critical locations to be tested and to have risk assessment documentation evidence in place for all cleanrooms on site. This project was critical for regulatory bodies including the FDA- I created a particulate (NVA) Risk Assessment for the compliance of ISO-14644-1_2015 across all cleanrooms on site. This was a necessity for the revalidation of each cleanroom to remain compliant and to aid external vendors with re-qualifications.- I set up a visual display tracker in the Microbiology Department for easier environmental monitoring trace-ability across all cleanrooms on site. Show less

  • QA Intern - (QMS) Quality Management Systems

    Oct 2016 - Apr 2017

  • Quality Assurance Graduate Intern - Microbiology

    Jan 2016 - Nov 2016
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  Regeneron pharmaceuticals, inc.

  Apr 2017 - Feb 2019

  - Logging, receiving and processing movements of all routine and non-routine manufacturing,QA validation, and Process Science samples on site designated for QC within (LIMS)Laboratory Information Management System- Participates in the transfer of methodology from test facilities (LIMS Sample Creation) aswell as adding test methods to samples on LIMS prior testing for all samples on site.- Sub-aliquotting of stability, retain samples and product batch samples that require multipleQC testing- Performs Urgent Endotoxin sample analysis in accordance with standard operating procedure(SOPs) with quick turnover for manufacturing dependent batch- Initiate and complete CAPAs /Change Controls and also laboratory investigations, generatingreports in response to invalid assays, Deviations, OOS/OOT.- Responsible for maintaining CTU (Controlled Temperature Unit) using Blue Mountain(BMRAM) for inventories, cleaning activities and performing daily temperature and relativehumidity monitoring of all QC CTUs using QBAS- Complete own test records on time and peer reviews data from other analysis for accuracyand completeness.- Proactively identifies and implement lab process improvements, lean initiatives.- Microbiology representation and participation in cross functional site meetings.- Administration of programs such as gowning, training, ordering, calibration, etc.- Ensures that all work carried out is in compliance with the required regulatory standardsconfirms to company policies and standard operating procedures (SOPs). Show less -Enters a Laboratory Cleanroom to collect and log samples for microbial analysis.- Performs environmental monitoring including surface, settling and viable and non-viableparticulate air monitoring- Performs acceptance testing of commercially prepared microbiological culture media.- Complete own test records on time and peer reviews data from other analysis for accuracyand completeness.- Participate in microbiology validations as needed for drug substance, in-process controls,buffers and clean utilities qualification program.- Assist manufacturing personal in the identification of microbiological root cause analysisand provide technical advice as needed.- Maintains laboratory reagents, media and supplies.- Conducts laboratory investigations and generates reports in response to invalid assays,Deviations, OOS/OOT.- Writes new and updates current SOPs as needed.- Presents analytical data reports clearly and concisely to management.- Proactively identifies and implement lab process improvements, lean initiatives. Show less

  • QC Sample Managment Analyst II

    Feb 2018 - Feb 2019

  • QC Microbiologist

    Apr 2017 - Feb 2018
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  Csl behring

  Mar 2020 - Jul 2024

  A Commissioning and Qualification Project Engineer working on a Tier 1 Capital Project in CSL Behring Broadmeadows, Melbourne Australia. - Lead Engineer of 5 Central Buffers Vessels and Distribution to Fractionation process tanks: HCL/NaOH/NaCl/NaAc-Write project documentation (URS, Risk Analysis, Protocols, Reports, Traceability Matrix, Design Specifications, Functional Specification) in accordance with cGMP guidelines and company procedures. (Kneat / Veeva)- Execute commissioning and qualification validation protocols; IQ, OQ, PQ.- Co-ordinate qualification execution activities, including external vendors, internal departments support, organizing materials, and budgeting.- Manage associated qualification deviations, Change Controls & CAPAs,- Participate in the creation and review of process Risk Assessments Commissioning / IQ Execution Tasks:- Flush and Pressure testing- Remediations and Passivation (CIP200)- Dead leg verifications- Process drain verifications- Updating of Design Specifications Documentation (DS)- Equipment and Instrument list and Vendor QA Inspection Report verifications-Design Risk Assessments (DRA) / System Risk Assessments (SRA)Commissioning / Operation Qualification tasks:- Safety Interlock tests- Automation Graphic Verifications- Functional Verifications (CIPs, Buffer Make, Buffer transfers, Instance QOS Signal Testing)- Spray Coverage Verifications- Mixing Study Verifications- Instrument Calibration Verification- Functional Speciation, URS Process fit verifications- Support with Shakedowns, PPQs and operation handoversAutomation Systems-Siemens (PCS7)-JAG-COMOS-Kneat-MES-Documentum-VeevaManaging of multiple contractors/external vendors as well as financial forecasting and budgeting. Support with deviations, remediation, change controls and process optimisations. Show less Process and Cleaning Validation responsibilities: -Write/ Prepare and Execute Cleaning & Process Validation Protocols and Reports.- Conducted swab sampling, rinse sampling, visual inspections, and other testing methodologies to evaluate the effectiveness of cleaning processes.- Collaborated with cross-functional teams including Quality Assurance, Manufacturing, Engineering, and Regulatory Affairs to support cleaning validation activities and resolve validation-related issues.- Provided technical expertise and guidance on cleaning validation principles, practices, and regulatory expectations to project teams and stakeholders.- Ensured documentation and records related to cleaning validation activities are accurate, complete, and maintained in compliance with regulatory requirements.- Conducted periodic reviews of cleaning validation programs and procedures to identify areas for improvement and ensure continuous compliance.- Supported regulatory inspections and audits related to cleaning validation activities.-Deviation Management-Ensured effective change management and change control -Performing formal Risk assessment for process and cleaning changes Projects related to;-Introduction of new 1 billion dollar fractionation facility with extensive Cleaning field studies and cleaning Validation for PPQ across 3 modules. -Process and cleaning validations during Commercial Manufacturing lifecycle-Periodic Monitoring and Continued Process Verification across 6 manufacturing facility's Show less

  • CQV Project Engineer

    Mar 2023 - Jul 2024

  • Validation Engineer

    Mar 2020 - Mar 2023
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  Lonza

  Mar 2025 - now

  Cqv engineer