Performing Process and equipment Validation activities in clinical chemistry operations.Execution of Mixing, Cleaning and Characterization studies.Process support to manufacturing area.Liase with vendors and contractors on projects.Participation in cross functional teams.EHS committee member.

Supporting the introduction, development and validation of high speed automated pen needle lines and associated products within the BD Dun Laoghaire site.Participation in FAT and SAT activities and execution of IQ,OQ protocols and TMV on high volume and bench top equipment.Characterisation & testing of new equipment & products and supported ramp up and training to high volume production.Performed New Instrument Additions and tracking of calibration schedule for lab and pilot/prototype equipment.Participated in Process Development of new equipment to establish suitable KPIV and determine impact of KPI on the process.Attended weekly design reviews with core team and active contributor in incremental design changes to resolve known weaknesses that existed in the previous generation of equipment.Updated SOP's and WI'S to reflect new products and processes.Delivered training on new equipment to Technicians and Operators and ensured high standard of knowledge transfer.Worked with vendors to design and deliver bench top testing solutions.Performed testing of new equipment and products to ensure suitability against URS/specifications.

Performed quality control sampling and testing of incoming raw materials and production components in accordance with regulatory and company standards Including Dimensional, functional and visual inspection.Liaised with suppliers to ensure acceptable standards of incoming materials,Recorded legal and retention samples on the quality control system,Worked closely with planning department to ensure timely release of components to meet tight build schedules.Archived completed documentation with retention samples in line with current regulatory practice.

Setup of Libra washer/Vial filling and Alu 400 capper machine in graded production area in accordance with cGMP,SOPs and batch manufacturing files.Performing area clearance and verifications prior to and after batch production.Completed L.S.S. Training and acquired yellow belt certification on completion of project.Visual inspection and sampling of finished product.Creation of test sets for Visual Inspection qualifications.

Co-ordinated the operation of the low volume prototype development area.Scheduling of experiments through online planning and post system.Conducted trial testing of pilot products from development stage to high volume manufacturing.Participated in tooling development and control parameter settings.Provided point of contact for engineering department.Assisted in product update roll outs to high volume manufacturing lines.Provided feedback on product characterisation and proposed cps settings.

Co ordinated the running of a high volume 24/7 thermal ink jet production area.Delegated tasks on a daily basis of 14 operator production shift.Completed cycle counts and process audits using SAP and document control management.Delivered training to new and existing hires and ensured they had the support to complete sign off. Focused the team on safety, performance and quality.Ensured that bill of materials were met as per planning requirements.Presented one to one and team training to process operators.Revised quality acceptance criteria for C.P.M(continuous process monitoring).Updated and edited sop's and cps settings and performed audits to ISO 9001.Completed pallet truck training with new employees.Trained operators on SAP system (IJ1 R3).Reported metrics at team meetings.

Operated a high volume inkjet production line,Performed interventions and monitored yield and line issues,Completed start of shift checks and in process tests,Ordered stock on S.A.P. system,Reported line issues to process co-ordinator.