Lead Process Engineer

Key Responsibilities:

Our Client, a Global Pharmaceutical leader, are looking for a Lead Process Engineer to manage Product/Process engineering projects on-time, and on budget for EMEA strategic capital projects and will be required to work with Global and local EMEA management teams in each European location to:
Develop process follow diagrams and studies for equipment and systems as appropriate for each location
Prepare with appropriate local resources conceptual studies for potential projects/new builds and equipment installations.
Prepare initial capital cost estimates for projects
Work with Global Engineering and local equipment and process SME's to ensure fit for purpose equipment and process trains for product pipelines,
Putting in place project programmes for the delivery of projects,
Oversee the tender process in conjunction with site management and the EMEA senior Project Manager
Ensuring delivery of projects against schedule and budget
Supporting with FAT, SAT and validation activities
Conducting HAZOP studies in conjunction with site engineering, EHS and vendors
Support the implementation of OEE reviews on equipment and process streams
Ensuring cGMP and regulatory compliance of new systems and equipment.
Support the Site engineering teams on the selection and URS development of clean utilities such as Purified Water, WFI and Clean Steam.
Manage key equipment and new system installation projects for EMEA strategic capital projects
Providing regular reports on cost, schedule, and risk to stakeholders.
Communicate effectively with the business customer(s) and senior management, providing regular reports on budget/cost, schedule and risk, as well as ensuring project work is meeting goals and prioritise.

Key Requirements:
Possess advanced ability to write technical/project status reports
Have advanced analytical skills and expert ability to effectively prioritise and execute tasks in a high pressure environment
Knowledge of technical operations functions within a regulated manufacturing company
Proven experience of developing equipment an system URS's and technical specifications within the pharmaceutical industry including Sterile/Aseptic processing, Oral Solid Dose and Drug Product Introduction
Demonstrated leadership skills - ability to develop process/technical solutions for complex problems which require the regular use of ingenuity and creativity.
Experience of cGMPs and regulatory guidelines
Experience and knowledge of system validation requirements such as ASTM 2500
Collaborative work style and networking relationships with customers, consultants and third party vendors
Detailed knowledge of the development and delivery of commercial facilities in a multinational context
Demonstrated ability of project management skills and ability to deliver projects on schedule and to budget.
Ideally possess a third level degree (or equivalent) and extensive experience within the field