We are currently looking for a Process Engineer to participate in upcoming projects, technical transfers from other sites, development in scale up and process improvements to established processes. You will be responsible for the management of Process and/or Production works/projects assigned to the role on site.
· Implement all Process/Production related projects within area of work in compliance with all relevant legislation and regulatory standards including HSE and Quality, and in accordance with the Project Engineering department ways of work.
· Participate in / lead technical transfer or process improvement projects for established process utilizing best available technology, practices and tool as appropriate at all times. These include the use of Lean Manufacturing Techniques, Risk Assessment Technology, Quality by Design, etc.
· Ensure all project risk assessments are carried out in a compliant manner in line with established SOP's and policies.
· Responsible for preparation and review of /process engineering documentation including project plans and cost proposals, validation plans and execution of validation activities in relation to projects, preparation of validation reports, etc., correctly in a timely manner, while liaising with the Quality Department as required.
· Responsible for on-time project delivery, projects delivery within budget, maintenance of validation status for all project related equipment to the required regulatory standards.
· Investigate and document process/production and project related deviations, planned deviations, out of specification results and implementation of agreed corrective actions as appropriate.
· Initiate, document and process change controls for project process/engineering related matters as appropriate.
· Present a written monthly report to the Manufacturing Director providing details on agreed KPI's and metrics.
· BSc / BEng, Msc / MEng, Phd in chemical engineering or equivalent.
· Good capacity for the execution and coordination of all Production activities.
· Experience in cGMP's and HSEE rules.
· Experience working within the pharmaceutical industry.
· Experience in equipment and technology design, selection, testing and procurement.
· Experience in technical manufacturing support.
· Tech transfer, capital project support, and start-up experience of multiple projects and product from early stage development to commercial scale.
· Experience in Production operations, trouble shooting.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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