Project managing decommissioning and rebuild of base fractionation plant from pilot scale to commercial scale; incorporating new utility packages, process equipment and laboratory facilities.

Leading Project Team at North Ryde site on Business, Process and Equipment improvements.

Leading a Safety uplift program at the North Ryde site.Leading a Decommissioning/CoGS reduction project across 8 production lines.

Engineering Lead and Project Manager in Capital Projects team.Responsible for design, procurement, construction, installation, commissioning and qualification as well as project control, budget, risk and resource management. Project is part of a $200M (AUD) investment in the North Ryde expansion programme.Additional Project Management responsibility for Sterilisation expansion and Microbiology laboratory upgrades.

• Workstream Lead for Process Improvement across 2 new cleanrooms and sterilisation suite as part of a $42M site development program• Workstream Lead for Equipment and Process Validation covering specification, design, installation, commissioning and process validation through to commercial production• Investigating process improvements, identifying and leading LEAN improvements via removal/reducing waste, investigation of automation on production and inspection processes, and control systems design for SCADA/ERP/Process Control systems • Technical authority for HAZOP, risk assessment, project risk management, approval of designs and vendor specifications• Detailing Critical to Quality (CTQs) aspects of products and processes, vendor management and collaboration with principal contractor to enable full definition of User Requirement Specifications (URS) across 80+ process equipment types• Communicating and collaborating with internal and external stakeholders to ensure design meets all requirements

• Technical leadership of Engineering in three diverse product areas: PTFE,Triplex and Endovascular departments• Deputising for Head of Engineering, with line management, coaching, development and mentorship of direct team of 6 and leadership of a multi-skilled engineering team of 28• Extensive gap analysis and process mapping of product and process validations and formulation a Master Validation Plan and Strategy for remediation, and further developed an ongoing revalidation programme based on process risk assessment • Author of IQ/OQ/PQ/PV Validation Protocols and Reports, as well as Process Verification for new/existing processes• Ownership for yield recovery, process improvement activity, equipment overhaul, upgrade and replacement• Introduction of OEM NPI product with process development, costings, validation plan• Leading Non-conformance and CAPA process investigations, and coaching team on methodologies for establishing root cause, solution implementation and closure• Leading comprehensive PFMEA studies, with project management of study outputs to improve the process design• SME for oven process controls, wet processes, validation and PTFE, Triplex and Endovascular product ranges• Workstream leader for product identification, segregation and manufacturing within a regulatory product re-submission

• Management of the Facility and Process Engineering functions in expanded facility covering Powder Milling and Liquid Media Manufacturing Suites• Leadership role on site management team, leading the engineering team to maintain and improve the facility and equipment to ensure operational availability, reliability and cost effectiveness• Leading the commissioning and validation programmes across multiple functions for new Milling lines • Leadership and management of capital projects and budget process for immediate through to 5-year plans• Implementing preventative maintenance programs and contract maintenance agreements with vendors to ensure continuous facility uptime• Leading Engineering team on new equipment troubleshooting through to equipment resolution and learning • Collaboration with Supply Chain, Manufacturing and Quality for the procurement, installation, start-up, validation and calibration of new and existing equipment• Leadership role in the promotion of health, safety, environmental compliance including continuous improvement initiatives to improve behavioural safety

• Engineering leadership for Polyester Manufacturing area covering equipment, maintenance and process validation• Deputising for Manufacturing Engineering Manager, leadership of a multi-skilled engineering team• Project management of Process Improvements, Yield improvements, new equipment and Automation• IQ/OQ/PQ/PV Validation and Verification of new processes and equipment including use of statistical data analysis tools• Significant gap analysis studies to map existing product and process validations and formulate the Master Validation Plan and remediation plans• Process Development on OEM products, including tooling and material design, reducing process variation and outsourcing of non-core elements• Detailed incident investigation using CAPA processes through to resolution, implementation and closure• Use of lean tools including Value Stream Mapping to prioritise strategic requirements on short, medium and long term plans• Leading and conducting PFMEA studies, risk management and root cause analysis to mitigate product, process and design issues • Experimental and conceptual process design, testing of new processes using structured protocols• Leading collaboration with academic and industrial partners on process design, tooling design and automation• Mentoring University student placements, sponsoring projects and coaching technical and soft skills in young engineers

Start-up of new filling lines in new factory, site management of original manufacturing site• Started-up a new aerosol production facility in January 2012, and site managed Auchinleck site for 3 months• Project managing and start-up of two new aerosol manufacturing lines in new custom-built facility and associated plant equipment including commissioning• Leading commissioning of new lines including improvements in line design, layout, process flow and downtime reduction• Conducting Risk Assessments, authoring Safety Critical Procedures, process/system redesign, ensuring compliance with HSE, SEPA and BAMA standards• Recruitment of production teams, organisational design/team structure, training/team framework• Setting 2012 production strategy for 2 sites, KPIs/metric setting, budget formulation, resource planning • SAP implementation, training, development of processes• Setting strategy for LEAN culture, training, and use of CI tools and teams• Involvement with BRC and customer audits, setting standards for GMP in new facility• Design of OEE data capture system, scoping project and sourcing solutions

Shift Management role, leading improvement projects as well as daily production• Front line leadership of multi disciplinary team in a high-volume process manufacturing environment• Extensive experience of implementation and sustaining of 5S tools, and Six Sigma principles including Kaizen improvements, and lean manufacturing projects• Responsible for all H&SE on-site, including deputising for Plant Manager• Responsible for coaching, delegation, exception managing, and support of team• Responsible for delivery to quality, time and cost metrics, multi-tasking across functions to set priorities • Motivating and development of team of 24 to ensure focus on customer and productivity, and promoting and mentoring continuous improvement initiatives

11 month secondment leading CI projects across 2 manufacturing sites• 6 Sigma Green Belt trained and implementation of an engineering maintenance project on MTBF• Project Leader for OEE and measurement system improvement project• Training of ~200 operations staff on Plant Yield, Loss recording, and Measurement Systems Improvements• Kaizen leader on multiple projects including process flow, capacity planning, optimisation and commissioning• 5S Champion across two manufacturing plants• Led the introduction of A3 Problem solving process• IBM BI (Business Intelligence) report writing, significant Excel report building experience, data management• Deputising for Continuous Improvement Manager• External networking including site visits to “Best Factory Awards” winners and reporting back to Manufacturing Director

Operational Management role following final commissioning of new R&D complex• Responsible for project handover and Project Management into beneficial operation of key new £68M scientific research and senior executive facility through to beneficial operation• Management and leadership of a multi-disciplinary team delivering engineering building services, first line support and logistics to a Scientific and Senior Managerial customer base of 380 people• Facilities and Engineering service management utilising internal and external supply services, Duty holder for all engineering services, revenue budget management of £550k• Driving the delivery and improvement in key logistics strategies utilising automated storage systems• Strategic leadership, forming, driving & implementing new ways of working, influencing and driving new facility support strategies

Plant Engineering role leading a maintenance team in PR&D Chemical plant• Capital Project Management and engineering responsibility for compliance and unit availability for batch manufacture of bulk product for the delivery of clinical trial products for 4 manufacturing units• Responsible for asset base worth £30M, Asset Owner for handover of 2 major capital projects (£15M and £2.5M) and maintenance spend of £850,000• Building manager controlling legionella, water systems, fire risk management, Pressure Systems legislation, Safety Instrumented Systems and Hazardous Area Legislation – reporting to Site Head on Compliance• Line management for multi-skilled technician team (unionised staff) and plant co-ordinators, including overtime management, competency development, training and hosting of monthly learning discussions• Change control – management of modifications in engineering projects and campaign manufacturing• Significant training in Risk Management, engineering controls, project management and people development

Project role in a PR&D Chemical production plant• Project and plant improvements• Design and commissioning experience of new assets• Technical assessor for qualification and validations• Spares rationalisation, control of quality critical parts and roll-out through SAP• Engineering Drawing rationalisation, creation of critical drawings register, management of modifications• Health, Safety and Environment – managing internal audit and compliance system• Occupational health monitoring• Mentor to local school project team and subsequently implemented through a Year in Industry student