BrightOwl Loader Loading


Skilled and Practised Process Supervisor and Operator, with a Wide Experience of the Chemical, Pharmaceutical, Medical Device and Light Engineering Industries, Highly Trained in Delivering Quality Output in a Regulated Environment Professional in Approach, with a Track Record of Taking Responsibility and Leading Teams in Achieving Results. Very Self-Motivated with a Logical Approach to Work. Enjoys Environments where there are Opportunities to Learn new Skills.


Current Experience

  • Aseptic operator
    Since January 2010
    DES Fusion Cell My role is to perform a set number of worksteps within the Fusion Cell to achieve the production of a completely finished drug-coated stent packaged and ready for sterilisation. Production to FDA Standards; GMP and GDP applied.  Line Clearance : removal of all previous batch material off the line, Clean down, sterilise the line in preparation for the next batch of stents.  Set up of batches for cell production – swat system, AS400 system  Perform the following worksteps within the cell  Pre-weigh – Weighing of stents prior to stents being coated by drug  Wet-weigh / Inspect Dry-weigh / Inspect – Weighing and inspection of stents after drug coating under microscope for any damage and Pass or Reject Stents by applying failure codes to rejected product  Load/Label Vial – Passed stents after Dry inspect are placed in vials in preparation for the next workstep and identified by the labelling of vials.  Final Inspect – Inspection of stent and catheter prior to final packaging of product and Pass or Reject Stents / Catheter by applying failure codes to rejected product  Accessory Attach – this is where the stent and catheter are associated together and various pieces of equipment attached to the unit e.g. identification chart prior to packaging  Pre-eto / Urania – This is where the completed unit is packaged and sealed and Labelled into specific pouches and placed into boxes to be sent for sterilisation and shipping  Ensure Product Building Targets are met, and document all work done during shift  All relevant Paperwork investigate any issues as they may arise  A3s / DMAIC – This is a process that allows to report and improve any issues which may arise within the cell and allows us to continuously improve systems within the cell infrastructure

Past Experience

  • Chemical Process Operator
    October 2001 --- July 2009
    See CV

  • Chemical Process Operator
    October 2001 --- July 2009
    Chemical Process Operator My role is to monitor and control the production of 5ISM and ISDN in the Nitration and Pharma Plants; these are used to treat heart disease. Production to FDA Standards; GMP and GDP applied.  Record and monitor manufacturing process steps from SCADA ( Computerised controlled System)  Identify current status of Batch Manufacturing Process by conducting shift handovers at the beginning and end of shifts  Obtained and reviewed the relevant Batch Manufacturing Instruction (BMI) to check status of the manufacturing process  Nitration Process Entailed: Raw Material Loading; Hydrolysis; Separation; Distillation; Purification; Centrifuging; Drying; Unload to drums; Move to Storage; Preform correct Cleaning procedures on plant and equipment  Pharma Process Entailed: Dispensing; Milling of Product-Particle sizing and Sampling; Blending; Unloading product from blenders; Sieving; Preform correct Cleaning procedures on plant and equipment  Calibrate PH metres and record result in Log Book and BMI  Retrieve Samples for Quality Control Testing Throughout the Process  Use of P.P.E. where required  Cleaning of all Rooms, Machinery and Equipment to Various Cleaning Levels as required  Identify and investigate any problems or blockages in the manufacturing process and advise supervisor if and when a Deviation Report is necessary  Transport Products to and from Warehouse by fork truck, All material movements governed by SAP  Maintain communication between Production, Laboratories and Warehouse throughout Batch Manufacturing Process  Review and Revise Nitration Plant S.O.P’s  Training of new operators of the manufacturing processes  Validation of equipment, processes and machinery


Self Assessment :
Analytical thinkingAttention to detailAuthenticityApproachabilityCollaborationAssertivenessCompetitivenessCoordinationCritical thinkingAdaptabilityDependability


LinkedIn Assessment :
LabellingVisual InspectionFirst Iine maintenanceInvestigationReporting & AnalysisBatch ProcessingBatch ControlBatch ProgrammingRoot Cause Analysis21 CFR Part 11Regulatory affairsISO 13485Quality AuditingQuality ManagementTestingPharmaceuticsCell Infrastructure5SDesign of ExperimentsFDAValidationIQ,OQ,PQSOPChange ControlPharmaceutical IndustryContinuous ImprovementLean ManufacturingSix SigmaManufacturingISOSAPMaterials ManagementSupply ChainQuality AssuranceProcess improvementMedical DevicesChemistryInventory ManagementCAPAWarehousingQuality SystemGMPProduct launchCross-functional team leadershipQuality ControlV&VKaizanA3DMAICPackaging Machinery

Skills and Expertise

Self Assessment :
Create SOPs Write protocolsAnalyse growth / improvement potential Analytical skills Lab scale batches Analyze data


  • Certificate in Behavioral based Safety from Alison Online Education in 2016
  • Diploma in Diploma in Workplace Health and Safety from Alison Online Education in 2016
  • Diploma in Project Management from Alison Online Education in 2016
  • Trade in from Fas Training in 1993
  • in Intermediate Certificate, Leaving Certificate from Saint Caimins Shannon in 1990

Training and Certification

  • Cell Manufacture in 2015 Training

Work Preferences

  • Notice Period:
    2 weeks
  • Positions I am interested in:
    GMP Operator Operations Operator Product Specialist Team Assistant Team Leader Technician
  • Positions I am NOT interested in:
    Account Executive Account Manager Account Manager - Life Sciences Administrative Assistant Assoc. RSU Specialist - Translation Coordinator Assistant Professor Associate Scientist Biomedical Scientist Associate Director Clinical Operations Associate Director - Head of Preclinical Immunology - Bacterial Vaccines associate Clinical Project Manager Biostatistics Masters graduate CEO Business Development Manager Business Consultant BioStatistician Chief Financial Officer (CFO) Chief Strategy Officer Clinical Data Manager (DM) Clinical Development Consultant Clinical Director Europe Clinical Laboratory Technician Clinical Operations Manager Clinical Project Leader Clinical Project Manager (CPM) Clinical Research Associate (CRA) Clinical Research Consultant Clinical Research Coordinator Clinical Research Manager Clinical Research Physician Clinical Safety Associate Clinical Study Nurse (SN) Clinical Supply Manager Clinical Trial Assistant (CTA) Clinical Trial consultant Clinical Trial Coordinator (CTC) Clinical Trial Manager (CTM) Clinical Trial Specialist (CTS) CMC Manager CMC Project Manager Compliance Manager
  • Locations I am interested in:
  • Work From Home:
  • Work Regime:
    Permanent position
    BrightOwl employee
  • International:

Area / Region

Shannon, Ireland


Driving License
  • Yes