Manage and direct the activities of MVS in order to provide an efficient, responsive, and cost effective maintenance, calibration and validation service to all parts of the Scottish National Blood Transfusion Service (SNBTS), in full compliance with the requirements of Good Manufacturing Practice and all other regulatory requirements.

•Evaluation of customer product's with a view to manufacturing capability (technology readiness level)•Define internal engineering capabilities, Identifying equipment, facilities requirements •Interface with customers (customer site visits)• Providing input to Manufacturing and Project Proposals on process development timescales, resource levels, assembly costs and budgets, and risks.• Planning and coordinating process design, development, validation and documentation, ensuring design is adequate for manufacture and assembly.• Responsibility for the planning and execution of development activities related to the manufacturing process • Performing necessary GMP process validations and other quality system documentation requirements to support new product development.• Preparing and maintaining records of all documentation, including drawings, sketches, calculations etc,

•Process review and optimisation of specified process areas, using application of world class manufacturing tools and techniques (Lean, ME2) .•Control and direct manufacturing validation (IQ,OQ,PQ) effort for existing and new processes.•Problem identification and resolution to root cause, using appropraite tools such as developing and improving planned maintenance programmes (FMECA’s).•Actively drived process improvement projects to achieve OEE targets for area of responsibility•Leadership and coordination of onsite Process Excellence initiatives•Followed and promoted Company, HS&E and Quality standards to enable the site to achieve and maintain excellent resultsQuality and Compliance Related Responsibilities•Ensured that all activities were carried out in compliance with all regulations and laws governing business and quality operations (FDA / GMP / BSI / ISO, etc.).•Initiation / completion of deviations, remedial actions, CAPA's and other quality system documentation.• Responsible for ensuring company compliance with all local, national, international and company regulations, policies and procedures for Health, Safety and Environmental compliance.

As part of a new product development team, I acted as the primary interface between the Biological lab development team and the Manufacturing system development partner.•Primary responsibilities were to ensure all critical to quality (CTQ) parameters of the assay consumable were built and validated into the automated manufacturing system.•Ensuring full technology transfer from the manufacturing system development partner to the facility, this included activities such as development of URS, equipment layouts,training etc.•Manage new plant and equipment installations, ensuring compliance with local EH&S guidelines.

Key member of an Operations Engineering department; whose primary role is for the Project Management of equipment installations, commissioning and validation of new production techniques and processes in order to support the needs of the business• Project managed the sourcing of new machines/ process in support of the Operations Strategic plan• Value of projects that I have managed have varied from £50,000 to £2 MM• Managing the installation and commissioning and validation of machines / manufacturing processes in line with current Quality System validation requirement’s• Providing Production Engineering support in terms of process validation and change control• Control of budgets within responsibility, ensuring spend on time and within budget• Work within multi-functional teams as required both as team leader and team member• Provide technical guidance to support departments (Production, Quality and Facilities etc), assisting to deliver a world class service• Review and create validation documentation to ensure protocols correctly challenge machines performance and regulatory requirements. (IQ, OQ, PQ etc)• Developing and improving planned maintenance programmes (FMECA’s).• Review of CMMS data, with specific emphasis on reliability engineering.• Participate and review OEE data to identify areas of continuous improvement

Lead member of a new product introduction team, responsible for the sourcing, installation and commissioning of new equipment in order to meet the needs of new product introduction.• Selected external suppliers and project managed the design, build and commissioning of automated production equipment• Project managed the installation and commissioning of machines / manufacturing processes in line with customer’s process requirements.• Provided Production Engineering support to the technicians• Managed the control of budgets within responsibility, ensuring spend on time and within budget

Member of a project development team reporting direct to the Technical Project Manager, responsibilities included: -• New product introduction to Automated production lines, dealing with issues such as tooling, Bill of Material errors etc• Resolved potential problems in all areas of automation installations and upgrades.• Undertook project management roles meeting tight budget and time targets.• Championed Year 2000 audits and tested all the automation equipment