Process Engineer

1 week ago

Dublin, Ireland Quanta part of QCS Staffing Full time

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Process 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 notifications by authoring/reviewing/approving investigations
Execute equipment/qualification validation programs, including re-qualification and re-validation
Perform data analysis and make informed decisions/recommendations based on data analysis
Conduct statistical data analysis to support development and commercialization batches
Support continuous improvement through Lean Six Sigma methodologies
Lead and actively participate in projects, system failure investigations, and report writing
Perform root cause analysis of system failures using standard tools and methods to resolve issues
Participate in and/or lead cross-functional or single-function teams, 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 5 years of related work experience in aseptic manufacturing/process engineering
Knowledge of regulatory and core requirements to Irish, European, and international standards and practices
Report writing, standards, and policy development skills required
Experience with equipment and process validation
Knowledge of sterile filling processes and equipment
Proficiency in Microsoft Office and related computer applications
Lean Six Sigma methodology experience is desirable
Excellent communication, presentation, and interpersonal skills for effective teamwork and external interactions
If you are interested, please apply now for immediate consideration and further information.

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