Michael Walker Email & Phone Number

County Carlow, Ireland

Responsible for providing site support for the deployment of lean and six sigma tools and methodsto ensure robust, reliable supply and lean manufacturing processes that delivers the highest Qualityproducts right first time in a safe and compliant manner.Specific responsibilities include:Provide cross functional support on all elements of the lean toolkit including value stream and process mapping, standard work, task breakdown sheets, visual management, tier process, 5S, Hoshin Kanri, wastes elimination, Kanban, Spaghetti Diagrams, Kaizen & KATA to ensure continuous improvement.Drive a Problem Solving culture by demonstrating strong problem solving skills, leading and active participation in system failure investigations using standard tools and methods e.g. FMEA, Fishbone diagrams, 5 Why’s to resolve issues and provide permanent corrective and preventative actions.Employee coaching & development - Lean Champion Mentor and delivering Masterclasses and using my coaching style to encourage and develop the confidence in colleagues who are learning to problem solve.Responsible for the company's Onboarding programme of all new starts to the site.Active member of the site’s Emergency Response Team since 2011 (ERT) and is one of the site's Incident Commander's.

County Carlow, Ireland

Specific responsibilities include:• Responsible for participating in C&Q and Validation activities to support start up.• Responsibility for the authoring of new / revised SOP's and Standard Work Instructions in the Component Preparation suite of the sterile facility.• Operate and monitor production support equipment such as parts washers, autoclaves, depyrogenation oven while using an automated system such as MES.• Maintain process equipment, completing preventative maintenance and equipment troubleshooting.• Responsible for the continuous supply of materials and components into the Component Preparation suite by using SAP tools.• Support continuous improvement by active participation in investigations and writing investigation reports for area Quality Notifications.• Perform root cause analysis using standard tools and methods to resolve system issues e.g. Fishbone diagram, 5 why’s.• Responsible for delivery of training, maintaining housekeeping, and 5S in all production areas while focusing on continuous process improvement using Lean Principles. • Execute current Good Manufacturing Practices (cGMP) in the performance of day to day activities and comply with Merck Global Policies, Procedures and Guidelines and regulatory requirements.• Active member of the site’s Emergency Response Team.• SAP, MES and LIMS application Superuser.

Rathdrum, Co. Wicklow

Specific responsibilities included:• Responsible for the manufacture of Active Pharmaceutical Ingredients (API’s) and associated intermediates in the production facility for process research, developmental purposes, clinical and commercial supply.• Operating processing units such as reactors, centrifuges, distillation equipment, filters, driers, feed tanks and their associated utilities and control systems.• Conducting trials in preparation for processing, setting –up for manufacture, batch processing and cleaning post-manufacture.• Charging and discharging materials to/from processing vessels.• Safe handling of flammable solvents and emergency response equipment.• Monitoring of Production equipment/manufacture using a PLC-SCADA control system.• To adhere to strict Schering-Plough / MSD policies and procedures in accordance with cGMP requirements.

Arklow, Co. Wicklow

Specific responsibilities included:• Sustaining manufacturing operations to insure a safe working environment that produces the highest quality product at the lowest cost.• Participating in Qualifications and Validation activities on new equipment / processes.• Developing and implementing improvements to existing processes and procedures.• Providing technical support to manufacturing.• Involvement in continuous improvement teams with the manufacturing department to improve quality and yield by using Lean and Six Sigma Principles.• Raw material troubleshooting and executing experiments in the production environment.• ERP Oracle Super-User for the Process Engineering group.Key Achievements include: Being a member of a number of project teams which led to:• 10% yield improvement in the last 18 months of Production.• Product quality and reliability improvements.• Successful new product implementation.• Transferring a robust process to sister company in Costa Rica for start up by training and coaching Costa Rican Process Engineers and Operators.• Leader of the management of all silicone raw material into production, improving visibility of wet raw material in the supply chain.• Lean Six Sigma Green Belt Certified – SQT Training

Arklow, Co. Wicklow

Based in the Incoming Inspection Laboratory.Specific responsibilities included: • To carry out inspection of material and product as defined in strict Allergan procedures in the Incoming Inspection area. • The sampling, testing, labelling of all raw materials such as Xylene, Silicone Dispersions, Silicone Gels and performing tests such as Viscosity, Percent Solids, Penetration and Cohesion tests to ensure that the material meets Allergan specifications. • The co-ordination, scheduling and maintenance of Allergan’s Pre – Processing test schedule. • Performing retesting of all raw material and to maintain the retest schedule within specific time frames. • To qualify and monitor all raw material requiring Cytotoxicity testing. • To ensure that accurate records of testing performed is recorded in accordance with good documentation practices. • Implement changes to area procedures via site change management system. • Review of Incoming Laboratory cGMP inspection files. Key Achievements include: • Being the Laboratory’s ERP Oracle Super-User and responsible for training of co- colleagues. • Successfully participated in 2 FDA and 2 LNE/G-MED audit inspections.

Diploma, Electrical, Electronics And Communications Engineering

Education record