Job Title: Process Engineer - Pharmaceuticals
This is a 11-month contract position to support multiple capital projects at a global pharmaceutical client's site in Carlow.
About the Role:
* Lead and execute production floor-based activities.
* Plan and execute qualification, validation activities as required.
* Design, author, review, approve, and execute process development studies in support of new product introduction and ongoing manufacturing support.
* Provide technical input into quality notifications by authoring, reviewing, and approving investigations.
* Execute equipment qualification validation programs, including re-qualification and re-validation.
* Design, author, review, approve, and execute qualification/validation documentation and studies in line with the standard approval process.
* Perform data analysis and make informed decisions/recommendations based on data analysis conclusions.
* 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 investigation reports.
* Develop and execute change controls.
* Perform root cause analysis of system failures and substandard performance using standard tools and methods to resolve machine and system issues.
Requirements:
* Prior related work experience, ideally in manufacturing, preferably in a GMP setting.
* Typically 5 years of related work experience in aseptic manufacturing/process engineering.
* Equipment and process validation experience.
* Experience with sterile filling processes and equipment.
* Lean Six Sigma methodology experience is desired.