Job Description
Project Engineer - Contract - Ireland
With worldwide demand for their life-changing oncology treatment increasing; one of our global pharmaceutical clients is looking for a Process Engineer to join their team to support multiple capital projects taking place onsite in Leinster.
This is a fantastic opportunity to work on a state-of-the art fill-finish facility and the company's first stand-alone vaccine and biologics plant outside the US.
Essential Duties and Responsibilities for this role include, but are not limited to, the following:
Lead/execute production floor-based activities
Participate on a team of engineers
Plan and execute C&Q, validation activities as required
Design & develop engineering studies
Provide technical input into quality notification by authoring/reviewing/approving investigations
Execution of equipment/qualification validation programs; including re-qualification and re-validation
Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis
Statistical data analysis to support development and commercialisation batches
Support continuous improvement through Lean Six Sigma methodologies
Leading and active participation in projects, system failure investigations and investigation reports
Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues
Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups
Requirements:
Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other technical discipline
Prior related work experience; ideally in manufacturing, preferably GMP Setting
Typically have 5 years related work experience in Aseptic manufacturing / process engineering
Knowledge of regulatory/core requirements to Irish, European and International Codes, Standards and Practices
Report, standards, policy writing skills required
Equipment and process validation
Sterile filling processes and equipment
Proficiency in Microsoft Office and job-related computer applications required
Lean Six Sigma Methodology experience desired
Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner
If you are interested initially, please apply now for immediate consideration and further information.
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